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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

Tradename:
ANGELIQ
Applicant:
Bayer Hlthcare
Ingredient:
drospirenone; estradiol
Patents:2
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 50419-482-03 3 BLISTER PACK in 1 CARTON (50419-482-03) > 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-01)
ANGELIQ
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:No
Patent:8,906,890Patent 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:6,933,395Patent Expiration:Aug 11, 2017Product Flag?Substance Flag?YDelist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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