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US Drug Approval A210622 – FDA – Mar 13, 2019

Children'S Cetirizine Hydrochloride Allergy

1 approved drug product. Children'S Cetirizine Hydrochloride Allergy Ingredients: Cetirizine Hydrochloride; Dosage form: syrup; Route of administration: oral; Strength: 5mg/5ml; Approval date: March 13, 2019; Marketing status: over-the-counter...
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US Drug Approval A202138 – FDA – Mar 13, 2019

Kemeya

1 approved drug product. Kemeya Ingredients: Drospirenone; Ethinyl Estradiol; Dosage form: tablet; Route of administration: oral-28; Strength: 3mg;0.03mg; Approval date: March 13, 2019; Marketing status: prescription.
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US Drug Approval A209476 – FDA – Mar 13, 2019

Sodium Chloride 3% in Plastic Container

1 approved drug product. Sodium Chloride 3% in Plastic Container Ingredients: Sodium Chloride; Dosage form: injectable; Route of administration: injection; Strength: 3gm/100ml; Approval date: March 13, 2019; Marketing status: prescription.
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US Drug Approval A211820 – FDA – Mar 12, 2019

Allopurinol

2 approved drug products. Allopurinol Ingredients: Allopurinol; Dosage form: tablet; Route of administration: oral; Strength: 100mg; Approval date: March 12, 2019; Marketing status: prescription. Allopurinol Ingredients: Allopurinol; Dosa...
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US Drug Approval A210267 – FDA – Mar 12, 2019

Tizanidine Hydrochloride

3 approved drug products. Tizanidine Hydrochloride Ingredients: Tizanidine Hydrochloride; Dosage form: capsule; Route of administration: oral; Strength: eq 2mg base; Approval date: March 12, 2019; Marketing status: prescription. Tizanidine H...
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US Drug Approval A210614 – FDA – Mar 12, 2019

Nifedipine

3 approved drug products. Nifedipine Ingredients: Nifedipine; Dosage form: tablet, extended release; Route of administration: oral; Strength: 30mg; Approval date: March 12, 2019; Marketing status: prescription. Nifedipine Ingredients: Nife...
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US Drug Approval A205536 – FDA – Mar 12, 2019

Valsartan

4 approved drug products. Valsartan Ingredients: Valsartan; Dosage form: tablet; Route of administration: oral; Strength: 40mg; Approval date: March 12, 2019; Marketing status: prescription. Valsartan Ingredients: Valsartan; Dosage form:...
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US Drug Approval A207569 – FDA – Mar 12, 2019

Loratadine

1 approved drug product. Loratadine Ingredients: Loratadine; Dosage form: tablet; Route of administration: oral; Strength: 10mg; Approval date: March 12, 2019; Marketing status: over-the-counter.
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US Drug Approval A212002 – FDA – Mar 12, 2019

Desonide

1 approved drug product. Desonide Ingredients: Desonide; Dosage form: ointment; Route of administration: topical; Strength: 0.05%; Approval date: March 12, 2019; Marketing status: prescription.
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US Drug Approval A209439 – FDA – Mar 11, 2019

Bleomycin Sulfate

1 approved drug product. Bleomycin Sulfate Ingredients: Bleomycin Sulfate; Dosage form: injectable; Route of administration: injection; Strength: eq 15 units base/vial; Approval date: March 11, 2019; Marketing status: prescription.
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US Drug Approval A204362 – FDA – Mar 11, 2019

Eptifibatide

1 approved drug product. Eptifibatide Ingredients: Eptifibatide; Dosage form: injectable; Route of administration: injection; Strength: 2mg/ml; Approval date: March 11, 2019; Marketing status: prescription.
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US Drug Approval A210158 – FDA – Mar 11, 2019

Dalfampridine

1 approved drug product. Dalfampridine Ingredients: Dalfampridine; Dosage form: tablet, extended release; Route of administration: oral; Strength: 10mg; Approval date: March 11, 2019; Marketing status: prescription.
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US Drug Approval A208445 – FDA – Mar 11, 2019

Potassium Chloride

2 approved drug products. Potassium Chloride Ingredients: Potassium Chloride; Dosage form: capsule, extended release; Route of administration: oral; Strength: 8meq; Approval date: March 11, 2019; Marketing status: prescription. Potassium Chl...
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US Drug Approval A208992 – FDA – Mar 11, 2019

Brimonidine Tartrate

1 approved drug product. Brimonidine Tartrate Ingredients: Brimonidine Tartrate; Dosage form: solution/drops; Route of administration: ophthalmic; Strength: 0.2%; Approval date: March 11, 2019; Marketing status: prescription.
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US Drug Approval A211064 – FDA – Mar 8, 2019

Folic Acid

1 approved drug product. Folic Acid Ingredients: Folic Acid; Dosage form: tablet; Route of administration: oral; Strength: 1mg; Approval date: March 8, 2019; Marketing status: prescription.
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US Drug Approval A211694 – FDA – Mar 8, 2019

Pyridostigmine Bromide

1 approved drug product. Pyridostigmine Bromide Ingredients: Pyridostigmine Bromide; Dosage form: syrup; Route of administration: oral; Strength: 60mg/5ml; Approval date: March 8, 2019; Marketing status: prescription.
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US Drug Approval A210028 – FDA – Mar 8, 2019

Atenolol and Chlorthalidone

2 approved drug products. Atenolol and Chlorthalidone Ingredients: Atenolol; Chlorthalidone; Dosage form: tablet; Route of administration: oral; Strength: 50mg;25mg; Approval date: March 8, 2019; Marketing status: prescription. Atenolol and...
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US Drug Approval A211023 – FDA – Mar 8, 2019

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: March 8, 2019; Marketin...
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US Drug Approval A204991 – FDA – Mar 6, 2019

Atorvastatin Calcium

4 approved drug products. Atorvastatin Calcium Ingredients: Atorvastatin Calcium; Dosage form: tablet; Route of administration: oral; Strength: eq 10mg base; Approval date: March 6, 2019; Marketing status: prescription. Atorvastatin Calcium...
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US Drug Approval A209202 – FDA – Mar 5, 2019

Esomeprazole Magnesium

1 approved drug product. Esomeprazole Magnesium Ingredients: Esomeprazole Magnesium; Dosage form: tablet, delayed release; Route of administration: oral; Strength: eq 20mg base; Approval date: March 5, 2019; Marketing status: over-the-counter....
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US Drug Approval A078545 – FDA – Mar 5, 2019

Lamivudine

2 approved drug products. Lamivudine Ingredients: Lamivudine; Dosage form: tablet; Route of administration: oral; Strength: 150mg; Approval date: March 5, 2019; Marketing status: prescription. Lamivudine Ingredients: Lamivudine; Dosage fo...
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US Drug Approval A209675 – FDA – Mar 5, 2019

Clonidine Hydrochloride

1 approved drug product. Clonidine Hydrochloride Ingredients: Clonidine Hydrochloride; Dosage form: tablet, extended release; Route of administration: oral; Strength: 0.1mg; Approval date: March 5, 2019; Marketing status: prescription.
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US Drug Approval A206066 – FDA – Mar 5, 2019

Bepotastine Besilate

1 approved drug product. Bepotastine Besilate Ingredients: Bepotastine Besilate; Dosage form: solution/drops; Route of administration: ophthalmic; Strength: 1.5%; Approval date: March 5, 2019; Marketing status: prescription.
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US Drug Approval A211800 – FDA – Mar 4, 2019

Clobetasol Propionate

1 approved drug product. Clobetasol Propionate Ingredients: Clobetasol Propionate; Dosage form: ointment; Route of administration: topical; Strength: 0.05%; Approval date: March 4, 2019; Marketing status: prescription.
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US Drug Approval A202544 – FDA – Mar 4, 2019

Telmisartan and Hydrochlorothiazide

3 approved drug products. Telmisartan and Hydrochlorothiazide Ingredients: Hydrochlorothiazide; Telmisartan; Dosage form: tablet; Route of administration: oral; Strength: 12.5mg;40mg; Approval date: March 4, 2019; Marketing status: prescriptio...
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US Drug Approval A206318 – FDA – Mar 4, 2019

Rivastigmine

3 approved drug products. Rivastigmine Ingredients: Rivastigmine; Dosage form: film, extended release; Route of administration: transdermal; Strength: 4.6mg/24hr; Approval date: March 4, 2019; Marketing status: prescription. Rivastigmine I...
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US Drug Approval A210044 – FDA – Mar 4, 2019

Fulvestrant

1 approved drug product. Fulvestrant Ingredients: Fulvestrant; Dosage form: injectable; Route of administration: intramuscular; Strength: 50mg/ml; Approval date: March 4, 2019; Marketing status: prescription.
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US Drug Approval A207818 – FDA – Mar 1, 2019

Imatinib Mesylate

2 approved drug products. Imatinib Mesylate Ingredients: Imatinib Mesylate; Dosage form: tablet; Route of administration: oral; Strength: eq 100mg base; Approval date: March 1, 2019; Marketing status: prescription. Imatinib Mesylate Ingred...
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US Drug Approval A209430 – FDA – Mar 1, 2019

Dapsone

2 approved drug products. Dapsone Ingredients: Dapsone; Dosage form: tablet; Route of administration: oral; Strength: 25mg; Approval date: March 1, 2019; Marketing status: prescription. Dapsone Ingredients: Dapsone; Dosage form: tablet;...
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US Drug Approval A211368 – FDA – Mar 1, 2019

Pantoprazole Sodium

1 approved drug product. Pantoprazole Sodium Ingredients: Pantoprazole Sodium; Dosage form: tablet, delayed release; Route of administration: oral; Strength: eq 40mg base; Approval date: March 1, 2019; Marketing status: prescription.
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US Drug Approval A205056 – FDA – Mar 1, 2019

Perphenazine

4 approved drug products. Perphenazine Ingredients: Perphenazine; Dosage form: tablet; Route of administration: oral; Strength: 2mg; Approval date: March 1, 2019; Marketing status: prescription. Perphenazine Ingredients: Perphenazine; Dos...
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US Drug Approval A206513 – FDA – Mar 1, 2019

Rosuvastatin Calcium

4 approved drug products. Rosuvastatin Calcium Ingredients: Rosuvastatin Calcium; Dosage form: tablet; Route of administration: oral; Strength: 5mg; Approval date: March 1, 2019; Marketing status: prescription. Rosuvastatin Calcium Ingredi...
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US Drug Approval A211655 – FDA – Feb 28, 2019

Oxybutynin Chloride

3 approved drug products. Oxybutynin Chloride Ingredients: Oxybutynin Chloride; Dosage form: tablet, extended release; Route of administration: oral; Strength: 5mg; Approval date: February 28, 2019; Marketing status: prescription. Oxybutynin...
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US Drug Approval A208380 – FDA – Feb 27, 2019

Abiraterone Acetate

1 approved drug product. Abiraterone Acetate Ingredients: Abiraterone Acetate; Dosage form: tablet; Route of administration: oral; Strength: 250mg; Approval date: February 27, 2019; Marketing status: prescription.
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US Drug Approval N212038 – FDA – Feb 27, 2019

Adhansia Xr

6 approved drug products. Adhansia Xr Ingredients: Methylphenidate Hydrochloride; Dosage form: capsule, extended release; Route of administration: oral; Strength: 25mg; Approval date: February 27, 2019; Marketing status: prescription. Adhans...
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US Drug Approval A211125 – FDA – Feb 27, 2019

Oseltamivir Phosphate

1 approved drug product. Oseltamivir Phosphate Ingredients: Oseltamivir Phosphate; Dosage form: for suspension; Route of administration: oral; Strength: eq 6mg base/ml; Approval date: February 27, 2019; Marketing status: prescription.
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US Drug Approval A205600 – FDA – Feb 27, 2019

Levofloxacin

1 approved drug product. Levofloxacin Ingredients: Levofloxacin; Dosage form: solution/drops; Route of administration: ophthalmic; Strength: 1.5%; Approval date: February 27, 2019; Marketing status: prescription.
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US Drug Approval A210748 – FDA – Feb 27, 2019

Azacitidine

1 approved drug product. Azacitidine Ingredients: Azacitidine; Dosage form: powder; Route of administration: intravenous, subcutaneous; Strength: 100mg/vial; Approval date: February 27, 2019; Marketing status: prescription.
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US Drug Approval A211063 – FDA – Feb 26, 2019

Chlorthalidone

2 approved drug products. Chlorthalidone Ingredients: Chlorthalidone; Dosage form: tablet; Route of administration: oral; Strength: 25mg; Approval date: February 26, 2019; Marketing status: prescription. Chlorthalidone Ingredients: Chlorth...
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US Drug Approval A210000 – FDA – Feb 26, 2019

Azithromycin

1 approved drug product. Azithromycin Ingredients: Azithromycin; Dosage form: tablet; Route of administration: oral; Strength: eq 250mg base; Approval date: February 26, 2019; Marketing status: prescription.
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US Drug Approval A210634 – FDA – Feb 26, 2019

Hydroxyzine Hydrochloride

1 approved drug product. Hydroxyzine Hydrochloride Ingredients: Hydroxyzine Hydrochloride; Dosage form: syrup; Route of administration: oral; Strength: 10mg/5ml; Approval date: February 26, 2019; Marketing status: prescription.
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US Drug Approval A210001 – FDA – Feb 26, 2019

Azithromycin

1 approved drug product. Azithromycin Ingredients: Azithromycin; Dosage form: tablet; Route of administration: oral; Strength: eq 500mg base; Approval date: February 26, 2019; Marketing status: prescription.
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US Drug Approval A206191 – FDA – Feb 25, 2019

Metronidazole in Plastic Container

1 approved drug product. Metronidazole in Plastic Container Ingredients: Metronidazole; Dosage form: injectable; Route of administration: injection; Strength: 500mg/100ml; Approval date: February 25, 2019; Marketing status: prescription.
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US Drug Approval A207420 – FDA – Feb 25, 2019

Omega-3-Acid Ethyl Esters

1 approved drug product. Omega-3-Acid Ethyl Esters Ingredients: Omega-3-Acid Ethyl Esters; Dosage form: capsule; Route of administration: oral; Strength: 1gm contains at least 900mg of the ethyl esters of omega-3 fatty acids; Approval date: Feb...
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US Drug Approval A208371 – FDA – Feb 25, 2019

Abiraterone Acetate

1 approved drug product. Abiraterone Acetate Ingredients: Abiraterone Acetate; Dosage form: tablet; Route of administration: oral; Strength: 250mg; Approval date: February 25, 2019; Marketing status: prescription.
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US Drug Approval A210148 – FDA – Feb 22, 2019

Busulfan

1 approved drug product. Busulfan Ingredients: Busulfan; Dosage form: injectable; Route of administration: injection; Strength: 6mg/ml; Approval date: February 22, 2019; Marketing status: prescription.
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US Drug Approval A205136 – FDA – Feb 22, 2019

Meclizine Hydrochloride

3 approved drug products. Meclizine Hydrochloride Ingredients: Meclizine Hydrochloride; Dosage form: tablet; Route of administration: oral; Strength: 12.5mg; Approval date: February 22, 2019; Marketing status: prescription. Meclizine Hydroch...
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US Drug Approval A207575 – FDA – Feb 22, 2019

Gemcitabine Hydrochloride

2 approved drug products. Gemcitabine Hydrochloride Ingredients: Gemcitabine Hydrochloride; Dosage form: injectable; Route of administration: injection; Strength: eq 1gm base/vial; Approval date: February 22, 2019; Marketing status: prescripti...
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US Drug Approval A209097 – FDA – Feb 22, 2019

Methylprednisolone

5 approved drug products. Methylprednisolone Ingredients: Methylprednisolone; Dosage form: tablet; Route of administration: oral; Strength: 2mg; Approval date: February 22, 2019; Marketing status: prescription. Methylprednisolone Ingredien...
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US Drug Approval A211049 – FDA – Feb 22, 2019

Olmesartan Medoxomil

3 approved drug products. Olmesartan Medoxomil Ingredients: Olmesartan Medoxomil; Dosage form: tablet; Route of administration: oral; Strength: 5mg; Approval date: February 22, 2019; Marketing status: prescription. Olmesartan Medoxomil Ing...
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