Details for New Drug Application (NDA): 004782
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The generic ingredient in PREMARIN is estrogens, conjugated. There are three drug master file entries for this compound. Two 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 Action | Estrogen 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 | 0046-1100-52 | 1 BLISTER PACK in 1 CARTON (0046-1100-52) / 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: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.3MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | 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 | 004782-005 | Jan 26, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Wyeth Pharms | PREMARIN | estrogens, conjugated | TABLET;ORAL | 004782-003 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Wyeth Pharms | PREMARIN | estrogens, conjugated | TABLET;ORAL | 004782-004 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Wyeth Pharms | PREMARIN | estrogens, conjugated | TABLET;ORAL | 004782-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Wyeth Pharms | PREMARIN | estrogens, conjugated | TABLET;ORAL | 004782-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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