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Generated: October 17, 2018

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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. 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. Additional details are available on the estrogens, conjugated synthetic a profile page.
Summary for 020992
Tradename:CENESTIN
Applicant:Teva Branded Pharm
Ingredient:estrogens, conjugated synthetic a
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 21, 2002TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 24, 1999TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 24, 1999TE:RLD:Yes

Expired US 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;ORAL 020992-004 Mar 13, 2000 ➤ Sign Up ➤ Sign Up
Teva Branded Pharm CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-001 Jun 21, 2002 ➤ Sign Up ➤ Sign Up
Teva Branded Pharm CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-002 Mar 24, 1999 ➤ Sign Up ➤ Sign Up
Teva Branded Pharm CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-003 Mar 24, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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