BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Express Scripts
Argus Health

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076334

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NDA 076334 describes PREVIFEM, which is a drug marketed by Vintage Pharms Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the PREVIFEM profile page.

The generic ingredient in PREVIFEM is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

Summary for 076334

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076334

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREVIFEM ethinyl estradiol; norgestimate TABLET;ORAL-28 076334 ANDA Par Pharmaceutical 0603-7642 0603-7642-17 6 BLISTER PACK in 1 CARTON (0603-7642-17) > 1 KIT in 1 BLISTER PACK (0603-7642-01)
PREVIFEM ethinyl estradiol; norgestimate TABLET;ORAL-28 076334 ANDA Central Texas Community Health Centers 76413-121 76413-121-28 1 KIT in 1 CARTON (76413-121-28)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.25MG
Approval Date:Jan 9, 2004TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Johnson and Johnson
Chinese Patent Office
Farmers Insurance

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