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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Argus Health
Queensland Health

Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021355

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NDA 021355 describes ANGELIQ, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ANGELIQ profile page.

The generic ingredient in ANGELIQ is drospirenone; estradiol. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the drospirenone; estradiol profile page.

Summary for NDA: 021355

Formulation / Manufacturing:see details

Pharmacology for NDA: 021355

Suppliers and Packaging for NDA: 021355

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
drospirenone; estradiol
TABLET;ORAL 021355 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-482 50419-482-03 3 BLISTER PACK in 1 CARTON (50419-482-03) > 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-01)
drospirenone; estradiol
TABLET;ORAL 021355 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-482 50419-482-72 1 BLISTER PACK in 1 CARTON (50419-482-72) > 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-71)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG;0.5MG
Approval Date:Feb 29, 2012TE:RLD:Yes
Patent:► SubscribePatent Expiration:Oct 22, 2031Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;1MG
Approval Date:Sep 28, 2005TE:RLD:Yes
Patent:► SubscribePatent Expiration:Aug 11, 2017Product Flag?Substance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 021355

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
drospirenone; estradiol
TABLET;ORAL021355-002Sep 28, 2005► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Boehringer Ingelheim
Chinese Patent Office
Federal Trade Commission
US Department of Justice
Harvard Business School
Queensland Health

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