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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Johnson and Johnson
Queensland Health

Generated: June 23, 2018

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 is one patent 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 021355
Applicant:Bayer Hlthcare
Ingredient:drospirenone; estradiol
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
ANGELIQ drospirenone; estradiol TABLET;ORAL 021355 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-482 N 50419-482-03
ANGELIQ drospirenone; estradiol TABLET;ORAL 021355 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-482 N 50419-482-72

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;1MG
Approval Date:Sep 28, 2005TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Federal Trade Commission
US Department of Justice
Daiichi Sankyo
Boehringer Ingelheim

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