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Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200151

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NDA 200151 describes SELFEMRA, which is a drug marketed by Teva Pharms Usa and is included in one NDA. Additional details are available on the SELFEMRA profile page.

The generic ingredient in SELFEMRA is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for NDA: 200151

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Feb 3, 2014TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Feb 3, 2014TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Feb 3, 2014TE:AB1RLD:No


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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Healthtrust
Colorcon
Cantor Fitzgerald
Merck
Queensland Health
Daiichi Sankyo
Express Scripts
Mallinckrodt
Citi

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