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US Drug Approval A062055 – FDA – Nov 2, 2018

Erythromycin Ethylsuccinate

3 approved drug products. Erythromycin Ethylsuccinate Ingredients: Erythromycin Ethylsuccinate; Dosage form: granule; Route of administration: oral; Strength: eq 200mg base/5ml; Approval date: prior to January 1, 1982; Marketing status: prescr...
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US Drug Approval A062663 – FDA – Aug 17, 2016

Vancomycin Hydrochloride

5 approved drug products. Vancomycin Hydrochloride Ingredients: Vancomycin Hydrochloride; Dosage form: injectable; Route of administration: injection; Strength: eq 1gm base/vial; Approval date: July 31, 1987; Marketing status: prescription....
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US Drug Approval A040486 – FDA – Feb 27, 2015

Metaxalone

1 approved drug product. Metaxalone Ingredients: Metaxalone; Dosage form: tablet; Route of administration: oral; Strength: 400mg; Approval date: February 27, 2015; Marketing status: prescription.
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US Drug Approval A040675 – FDA – Dec 23, 2014

Phenylephrine Hydrochloride and Promethazine Hydrochloride

1 approved drug product. Phenylephrine Hydrochloride and Promethazine Hydrochloride Ingredients: Phenylephrine Hydrochloride; Promethazine Hydrochloride; Dosage form: syrup; Route of administration: oral; Strength: 5mg/5ml;6.25mg/5ml; Approval...
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US Drug Approval A040674 – FDA – Dec 23, 2014

Promethazine Hydrochloride, Phenylephrine Hydrochloride W/Codeine Phosphate

1 approved drug product. Promethazine Hydrochloride, Phenylephrine Hydrochloride W/Codeine Phosphate Ingredients: Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride; Dosage form: syrup; Route of administration: oral; Stre...
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US Drug Approval A040884 – FDA – Nov 28, 2014

Phenytoin

1 approved drug product. Phenytoin Ingredients: Phenytoin; Dosage form: tablet, chewable; Route of administration: oral; Strength: 50mg; Approval date: November 28, 2014; Marketing status: prescription.
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US Drug Approval A065306 – FDA – Aug 18, 2014

Cefazolin Sodium

2 approved drug products. Cefazolin Sodium Ingredients: Cefazolin Sodium; Dosage form: injectable; Route of administration: injection; Strength: eq 10gm base/vial; Approval date: October 22, 2008; Marketing status: prescription. Cefazolin So...
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US Drug Approval A040838 – FDA – May 10, 2013

Hydrocodone Bitartrate and Acetaminophen

1 approved drug product. Hydrocodone Bitartrate and Acetaminophen Ingredients: Acetaminophen; Hydrocodone Bitartrate; Dosage form: solution; Route of administration: oral; Strength: 325mg/15ml;7.5mg/15ml; Approval date: May 10, 2013; Marketing...
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US Drug Approval A065349 – FDA – Apr 25, 2013

Cefadroxil

2 approved drug products. Cefadroxil Ingredients: Cefadroxil/Cefadroxil Hemihydrate; Dosage form: for suspension; Route of administration: oral; Strength: eq 250mg base/5ml; Approval date: April 25, 2013; Marketing status: prescription. Cefa...
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US Drug Approval A040903 – FDA – Oct 24, 2012

Imipramine Hydrochloride

3 approved drug products. Imipramine Hydrochloride Ingredients: Imipramine Hydrochloride; Dosage form: tablet; Route of administration: oral; Strength: 10mg; Approval date: October 24, 2012; Marketing status: prescription. Imipramine Hydroch...
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US Drug Approval A065213 – FDA – Jul 25, 2012

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone

1 approved drug product. Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ingredients: Bacitracin Zinc; Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate; Dosage form: ointment; Route of administration: ophthalmic; Stren...
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US Drug Approval A040800 – FDA – Apr 3, 2012

Oxycodone and Acetaminophen

2 approved drug products. Oxycodone and Acetaminophen Ingredients: Acetaminophen; Oxycodone Hydrochloride; Dosage form: tablet; Route of administration: oral; Strength: 325mg;7.5mg; Approval date: April 3, 2012; Marketing status: discontinued....
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US Drug Approval A040859 – FDA – Mar 27, 2012

Norepinephrine Bitartrate

1 approved drug product. Norepinephrine Bitartrate Ingredients: Norepinephrine Bitartrate; Dosage form: injectable; Route of administration: injection; Strength: eq 1mg base/ml; Approval date: March 27, 2012; Marketing status: prescription.
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US Drug Approval A065351 – FDA – Feb 29, 2012

Cefprozil

2 approved drug products. Cefprozil Ingredients: Cefprozil; Dosage form: for suspension; Route of administration: oral; Strength: 125mg/5ml; Approval date: February 29, 2012; Marketing status: prescription. Cefprozil Ingredients: Cefprozil...
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US Drug Approval A040642 – FDA – Dec 6, 2011

Methscopolamine Bromide

2 approved drug products. Methscopolamine Bromide Ingredients: Methscopolamine Bromide; Dosage form: tablet; Route of administration: oral; Strength: 2.5mg; Approval date: December 6, 2011; Marketing status: prescription. Methscopolamine Bro...
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US Drug Approval A040872 – FDA – Jul 28, 2011

Phentermine Resin Complex

2 approved drug products. Phentermine Resin Complex Ingredients: Phentermine Resin Complex; Dosage form: capsule, extended release; Route of administration: oral; Strength: eq 15mg base; Approval date: July 28, 2011; Marketing status: disconti...
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US Drug Approval A040894 – FDA – Jul 19, 2011

Hydrocodone Bitartrate and Acetaminophen

1 approved drug product. Hydrocodone Bitartrate and Acetaminophen Ingredients: Acetaminophen; Hydrocodone Bitartrate; Dosage form: solution; Route of administration: oral; Strength: 325mg/15ml;7.5mg/15ml; Approval date: July 19, 2011; Marketin...
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US Drug Approval A040888 – FDA – Jul 18, 2011

Methylprednisolone Sodium Succinate

5 approved drug products. Methylprednisolone Sodium Succinate Ingredients: Methylprednisolone Sodium Succinate; Dosage form: injectable; Route of administration: injection; Strength: eq 1gm base/vial; Approval date: July 18, 2011; Marketing st...
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US Drug Approval A040911 – FDA – May 23, 2011

Lidocaine

1 approved drug product. Lidocaine Ingredients: Lidocaine; Dosage form: ointment; Route of administration: topical; Strength: 5%; Approval date: May 23, 2011; Marketing status: prescription.
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US Drug Approval A065286 – FDA – Mar 23, 2011

Aztreonam

2 approved drug products. Aztreonam Ingredients: Aztreonam; Dosage form: injectable; Route of administration: injection; Strength: 1gm/vial; Approval date: March 23, 2011; Marketing status: discontinued. Aztreonam Ingredients: Aztreonam;...
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US Drug Approval A040837 – FDA – Mar 23, 2011

Lidocaine Hydrochloride

1 approved drug product. Lidocaine Hydrochloride Ingredients: Lidocaine Hydrochloride; Dosage form: jelly; Route of administration: topical; Strength: 2%; Approval date: March 23, 2011; Marketing status: discontinued.
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US Drug Approval A040890 – FDA – Nov 1, 2010

Prednisone

1 approved drug product. Prednisone Ingredients: Prednisone; Dosage form: tablet; Route of administration: oral; Strength: 1mg; Approval date: November 1, 2010; Marketing status: discontinued.
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US Drug Approval A065362 – FDA – Oct 21, 2010

Piperacillin and Tazobactam

3 approved drug products. Piperacillin and Tazobactam Ingredients: Piperacillin Sodium; Tazobactam Sodium; Dosage form: injectable; Route of administration: injection; Strength: eq 2gm base/vial;eq 250mg base/vial; Approval date: October 21, 20...
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US Drug Approval A065363 – FDA – Oct 21, 2010

Piperacillin and Tazobactam

3 approved drug products. Piperacillin and Tazobactam Ingredients: Piperacillin Sodium; Tazobactam Sodium; Dosage form: injectable; Route of administration: injection; Strength: eq 2gm base/vial;eq 250mg base/vial; Approval date: October 21, 20...
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US Drug Approval A040889 – FDA – Sep 13, 2010

Methylergonovine Maleate

1 approved drug product. Methylergonovine Maleate Ingredients: Methylergonovine Maleate; Dosage form: injectable; Route of administration: injection; Strength: 0.2mg/ml; Approval date: September 13, 2010; Marketing status: prescription.
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US Drug Approval A040879 – FDA – Aug 20, 2010

Hydrocortisone

1 approved drug product. Hydrocortisone Ingredients: Hydrocortisone; Dosage form: cream; Route of administration: topical; Strength: 2.5%; Approval date: August 20, 2010; Marketing status: prescription.
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US Drug Approval A065356 – FDA – Jul 29, 2010

Doxycycline

4 approved drug products. Doxycycline Ingredients: Doxycycline; Dosage form: tablet; Route of administration: oral; Strength: eq 50mg base; Approval date: May 31, 2006; Marketing status: prescription. Doxycycline Ingredients: Doxycycline;...
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US Drug Approval A040771 – FDA – Jul 1, 2010

Triamcinolone Acetonide

1 approved drug product. Triamcinolone Acetonide Ingredients: Triamcinolone Acetonide; Dosage form: paste; Route of administration: dental; Strength: 0.1%; Approval date: July 1, 2010; Marketing status: prescription.
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US Drug Approval A040846 – FDA – Jun 9, 2010

Hydrocodone Bitartrate and Acetaminophen

1 approved drug product. Hydrocodone Bitartrate and Acetaminophen Ingredients: Acetaminophen; Hydrocodone Bitartrate; Dosage form: tablet; Route of administration: oral; Strength: 325mg;2.5mg; Approval date: June 9, 2010; Marketing status: pre...
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US Drug Approval A040849 – FDA – Jun 9, 2010

Hydrocodone Bitartrate and Acetaminophen

1 approved drug product. Hydrocodone Bitartrate and Acetaminophen Ingredients: Acetaminophen; Hydrocodone Bitartrate; Dosage form: tablet; Route of administration: oral; Strength: 650mg;5mg; Approval date: June 9, 2010; Marketing status: disco...
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US Drug Approval A040756 – FDA – Jun 4, 2010

Folic Acid

1 approved drug product. Folic Acid Ingredients: Folic Acid; Dosage form: tablet; Route of administration: oral; Strength: 1mg; Approval date: June 4, 2010; Marketing status: prescription.
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US Drug Approval A040659 – FDA – Jun 4, 2010

Meclizine Hydrochloride

2 approved drug products. Meclizine Hydrochloride Ingredients: Meclizine Hydrochloride; Dosage form: tablet; Route of administration: oral; Strength: 12.5mg; Approval date: June 4, 2010; Marketing status: prescription. Meclizine Hydrochlorid...
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US Drug Approval A040861 – FDA – Jun 1, 2010

Chlorzoxazone

2 approved drug products. Chlorzoxazone Ingredients: Chlorzoxazone; Dosage form: tablet; Route of administration: oral; Strength: 375mg; Approval date: June 1, 2010; Marketing status: prescription. Chlorzoxazone Ingredients: Chlorzoxazone;...
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US Drug Approval A040445 – FDA – Mar 31, 2010

Metaxalone

1 approved drug product. Metaxalone Ingredients: Metaxalone; Dosage form: tablet; Route of administration: oral; Strength: 800mg; Approval date: March 31, 2010; Marketing status: prescription.
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US Drug Approval A065238 – FDA – Mar 12, 2010

Cefoxitin

2 approved drug products. Cefoxitin Ingredients: Cefoxitin Sodium; Dosage form: injectable; Route of administration: injection; Strength: eq 1gm base/vial; Approval date: March 12, 2010; Marketing status: prescription. Cefoxitin Ingredient...
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US Drug Approval A065239 – FDA – Mar 2, 2010

Cefoxitin

1 approved drug product. Cefoxitin Ingredients: Cefoxitin Sodium; Dosage form: injectable; Route of administration: injection; Strength: eq 10gm base/vial; Approval date: March 2, 2010; Marketing status: prescription.
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US Drug Approval A040858 – FDA – Feb 26, 2010

Hydralazine Hydrochloride

4 approved drug products. Hydralazine Hydrochloride Ingredients: Hydralazine Hydrochloride; Dosage form: tablet; Route of administration: oral; Strength: 10mg; Approval date: February 26, 2010; Marketing status: discontinued. Hydralazine Hyd...
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US Drug Approval A040881 – FDA – Feb 25, 2010

Hydrocodone Bitartrate and Acetaminophen

1 approved drug product. Hydrocodone Bitartrate and Acetaminophen Ingredients: Acetaminophen; Hydrocodone Bitartrate; Dosage form: solution; Route of administration: oral; Strength: 300mg/15ml;10mg/15ml; Approval date: February 25, 2010; Marke...
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US Drug Approval A065348 – FDA – Jan 25, 2010

Cefotaxime Sodium

1 approved drug product. Cefotaxime Sodium Ingredients: Cefotaxime Sodium; Dosage form: injectable; Route of administration: injection; Strength: eq 10gm base/vial; Approval date: January 25, 2010; Marketing status: discontinued.
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US Drug Approval A040843 – FDA – Jan 11, 2010

Methotrexate Sodium Preservative Free

4 approved drug products. Methotrexate Sodium Preservative Free Ingredients: Methotrexate Sodium; Dosage form: injectable; Route of administration: injection; Strength: eq 1gm base/40ml (eq 25mg base/ml); Approval date: January 11, 2010; Marke...
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US Drug Approval A040832 – FDA – Jan 7, 2010

Carisoprodol and Aspirin

1 approved drug product. Carisoprodol and Aspirin Ingredients: Aspirin; Carisoprodol; Dosage form: tablet; Route of administration: oral; Strength: 325mg;200mg; Approval date: January 7, 2010; Marketing status: prescription.
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US Drug Approval A040860 – FDA – Jan 7, 2010

Carisoprodol, Aspirin and Codeine Phosphate

1 approved drug product. Carisoprodol, Aspirin and Codeine Phosphate Ingredients: Aspirin; Carisoprodol; Codeine Phosphate; Dosage form: tablet; Route of administration: oral; Strength: 325mg;200mg;16mg; Approval date: January 7, 2010; Marketi...
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US Drug Approval A065251 – FDA – Dec 30, 2009

Cefuroxime Sodium in Plastic Container

2 approved drug products. Cefuroxime Sodium in Plastic Container Ingredients: Cefuroxime Sodium; Dosage form: injectable; Route of administration: injection; Strength: eq 75gm base/vial; Approval date: December 30, 2009; Marketing status: disc...
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US Drug Approval A040882 – FDA – Dec 30, 2009

Promethazine Hydrochloride

1 approved drug product. Promethazine Hydrochloride Ingredients: Promethazine Hydrochloride; Dosage form: syrup; Route of administration: oral; Strength: 6.25mg/5ml; Approval date: December 30, 2009; Marketing status: prescription.
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US Drug Approval A040865 – FDA – Dec 29, 2009

Ergocalciferol

1 approved drug product. Ergocalciferol Ingredients: Ergocalciferol; Dosage form: capsule; Route of administration: oral; Strength: 50,000 iu; Approval date: December 29, 2009; Marketing status: prescription.
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US Drug Approval A065339 – FDA – Dec 22, 2009

Epirubicin Hydrochloride

2 approved drug products. Epirubicin Hydrochloride Ingredients: Epirubicin Hydrochloride; Dosage form: injectable; Route of administration: injection; Strength: 50mg/25ml (2mg/ml); Approval date: December 22, 2009; Marketing status: discontinu...
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US Drug Approval A040885 – FDA – Nov 16, 2009

Butalbital, Acetaminophen and Caffeine

1 approved drug product. Butalbital, Acetaminophen and Caffeine Ingredients: Acetaminophen; Butalbital; Caffeine; Dosage form: capsule; Route of administration: oral; Strength: 300mg;50mg;40mg; Approval date: November 16, 2009; Marketing statu...
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US Drug Approval A040851 – FDA – Nov 9, 2009

Benzonatate

3 approved drug products. Benzonatate Ingredients: Benzonatate; Dosage form: capsule; Route of administration: oral; Strength: 100mg; Approval date: November 9, 2009; Marketing status: prescription. Benzonatate Ingredients: Benzonatate; D...
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US Drug Approval A040647 – FDA – Oct 5, 2009

Testosterone Enanthate

1 approved drug product. Testosterone Enanthate Ingredients: Testosterone Enanthate; Dosage form: injectable; Route of administration: injection; Strength: 200mg/ml; Approval date: October 5, 2009; Marketing status: discontinued.
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US Drug Approval A040902 – FDA – Aug 25, 2009

Promethazine Hydrochloride and Phenylephrine Hydrochloride

1 approved drug product. Promethazine Hydrochloride and Phenylephrine Hydrochloride Ingredients: Phenylephrine Hydrochloride; Promethazine Hydrochloride; Dosage form: syrup; Route of administration: oral; Strength: 5mg/5ml;6.25mg/5ml; Approval...
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