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Details for New Drug Application (NDA): 010402
The generic ingredient in PREMARIN is estrogens, conjugated. There are three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the estrogens, conjugated profile page.
Summary for 010402
Tradename: | PREMARIN |
Applicant: | Wyeth Pharms Inc |
Ingredient: | estrogens, conjugated |
Patents: | 0 |
Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 010402
Ingredient-type | Estrogens, Conjugated (USP) |
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 010402
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREMARIN | estrogens, conjugated | INJECTABLE;INJECTION | 010402 | NDA | Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. | 0046-0749 | N | 0046-0749-05 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/VIAL | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Expired US Patents for NDA 010402
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Wyeth Pharms Inc | PREMARIN | estrogens, conjugated | INJECTABLE;INJECTION | 010402-001 | 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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