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Serving 500+ biopharmaceutical companies globally:

McKesson
McKinsey
Harvard Business School
Colorcon
Farmers Insurance
US Army
Queensland Health
Baxter
Cantor Fitzgerald
Fuji

Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075804

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NDA 075804 describes SPRINTEC, which is a drug marketed by Barr and is included in one NDA. It is available from two suppliers. Additional details are available on the SPRINTEC profile page.

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

Summary for NDA: 075804

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

Suppliers and Packaging for NDA: 075804

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPRINTEC
ethinyl estradiol; norgestimate
TABLET;ORAL-28 075804 ANDA Teva Pharmaceuticals USA, Inc. 0555-9016 0555-9016-58 6 POUCH in 1 CARTON (0555-9016-58) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK
SPRINTEC
ethinyl estradiol; norgestimate
TABLET;ORAL-28 075804 ANDA Rebel Distributors Corp 21695-769 21695-769-28 1 BLISTER PACK in 1 CARTON (21695-769-28) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.25MG
Approval Date:Sep 25, 2002TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cerilliant
US Army
Farmers Insurance
Teva
AstraZeneca
Novartis
Queensland Health
Argus Health
Cantor Fitzgerald
Baxter

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