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Generated: January 19, 2019

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Details for New Drug Application (NDA): 004782

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NDA 004782 describes PREMARIN, which is a drug marketed by Wyeth Pharms and is included in three NDAs. It is available from four suppliers. Additional details are available on the PREMARIN profile page.

The generic ingredient in PREMARIN is estrogens, conjugated. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estrogens, conjugated profile page.
Summary for 004782
Tradename:PREMARIN
Applicant:Wyeth Pharms
Ingredient:estrogens, conjugated
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 004782
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 004782
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREMARIN estrogens, conjugated TABLET;ORAL 004782 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0046-1100 0046-1100-51 1 POUCH in 1 CARTON (0046-1100-51) > 1 BLISTER PACK in 1 POUCH > 5 TABLET, FILM COATED in 1 BLISTER PACK
PREMARIN estrogens, conjugated TABLET;ORAL 004782 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0046-1100 0046-1100-81 100 TABLET, FILM COATED in 1 BOTTLE (0046-1100-81)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.3MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 004782

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-002 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-003 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-004 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-005 Jan 26, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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