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Details for New Drug Application (NDA): 020992

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NDA 020992 describes CENESTIN, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the CENESTIN profile page.

The generic ingredient in CENESTIN is estrogens, conjugated synthetic a. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, conjugated synthetic a profile page.

Summary for NDA: 020992

Tradename:
CENESTIN
Applicant:
Teva Branded Pharm
Ingredient:
estrogens, conjugated synthetic a
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020992

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CENESTIN
estrogens, conjugated synthetic a
TABLET;ORAL 020992 NDA Physicians Total Care, Inc. 54868-1432 54868-1432-0 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-1432-0)
CENESTIN
estrogens, conjugated synthetic a
TABLET;ORAL 020992 NDA Physicians Total Care, Inc. 54868-1432 54868-1432-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-1432-1)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.3MG
Approval Date:Jun 21, 2002TE:RLD:No
Patent:5,908,638Patent Expiration:Jul 26, 2015Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.625MG
Approval Date:Mar 24, 1999TE:RLD:No
Patent:5,908,638Patent Expiration:Jul 26, 2015Product Flag?Substance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.9MG
Approval Date:Mar 24, 1999TE:RLD:No
Patent:5,908,638Patent Expiration:Jul 26, 2015Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020992

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm
CENESTIN
estrogens, conjugated synthetic a
TABLET;ORAL020992-001Jun 21, 20025,908,638► subscribe
Teva Branded Pharm
CENESTIN
estrogens, conjugated synthetic a
TABLET;ORAL020992-004Mar 13, 20005,908,638► subscribe
Teva Branded Pharm
CENESTIN
estrogens, conjugated synthetic a
TABLET;ORAL020992-003Mar 24, 19995,908,638► subscribe
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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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