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 two 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. Three suppliers are listed for this compound. Additional details are available on the estrogens, conjugated profile page.
The generic ingredient in PREMARIN is estrogens, conjugated. There are three drug master file entries for this compound. Three 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 |
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: | AB | 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: | AB | 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 | 004782-001 | Approved Prior to Jan 1, 1982 | 5,210,081 | ⤷ Get Started Free |
| Wyeth Pharms | PREMARIN | estrogens, conjugated | TABLET;ORAL | 004782-005 | Jan 26, 1984 | 5,210,081 | ⤷ Get Started Free |
| Wyeth Pharms | PREMARIN | estrogens, conjugated | TABLET;ORAL | 004782-002 | Approved Prior to Jan 1, 1982 | 5,210,081 | ⤷ Get Started Free |
| Wyeth Pharms | PREMARIN | estrogens, conjugated | TABLET;ORAL | 004782-003 | Approved Prior to Jan 1, 1982 | 5,210,081 | ⤷ Get Started Free |
| Wyeth Pharms | PREMARIN | estrogens, conjugated | TABLET;ORAL | 004782-004 | Approved Prior to Jan 1, 1982 | 5,210,081 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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