Details for New Drug Application (NDA): 020527
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NDA 020527 describes PREMPRO, which is a drug marketed by Wyeth Pharms and Wyeth Pharms Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the PREMPRO profile page.
The generic ingredient in PREMPRO is estrogens, conjugated; medroxyprogesterone acetate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, conjugated; medroxyprogesterone acetate profile page.
The generic ingredient in PREMPRO is estrogens, conjugated; medroxyprogesterone acetate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, conjugated; medroxyprogesterone acetate profile page.
Summary for 020527
| Tradename: | PREMPRO |
| Applicant: | Wyeth Pharms |
| Ingredient: | estrogens, conjugated; medroxyprogesterone acetate |
| Patents: | 0 |
Pharmacology for NDA: 020527
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 020527
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREMPHASE 14/14 | estrogens, conjugated; medroxyprogesterone acetate | TABLET;ORAL-28 | 020527 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1105 | 0046-1105-11 | 1 BLISTER PACK in 1 CARTON (0046-1105-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK |
| PREMPHASE 14/14 | estrogens, conjugated; medroxyprogesterone acetate | TABLET;ORAL-28 | 020527 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1106 | 0046-1106-11 | 1 BLISTER PACK in 1 CARTON (0046-1106-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.625MG;2.5MG | ||||
| Approval Date: | Nov 17, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.625MG,0.625MG;N/A,5MG | ||||
| Approval Date: | Nov 17, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.625MG;5MG | ||||
| Approval Date: | Jan 9, 1998 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020527
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Wyeth Pharms | PREMPRO | estrogens, conjugated; medroxyprogesterone acetate | TABLET;ORAL-28 | 020527-001 | Nov 17, 1995 | 4,826,831 | ⤷ Subscribe |
| Wyeth Pharms | PREMPRO | estrogens, conjugated; medroxyprogesterone acetate | TABLET;ORAL-28 | 020527-003 | Jan 9, 1998 | RE36247 | ⤷ Subscribe |
| Wyeth Pharms | PREMPRO | estrogens, conjugated; medroxyprogesterone acetate | TABLET;ORAL-28 | 020527-003 | Jan 9, 1998 | 4,826,831 | ⤷ Subscribe |
| Wyeth Pharms | PREMPRO | estrogens, conjugated; medroxyprogesterone acetate | TABLET;ORAL-28 | 020527-005 | Jun 4, 2003 | 5,547,948 | ⤷ Subscribe |
| Wyeth Pharms | PREMPRO | estrogens, conjugated; medroxyprogesterone acetate | TABLET;ORAL-28 | 020527-004 | Mar 12, 2003 | RE36247 | ⤷ Subscribe |
| Wyeth Pharms | PREMPHASE 14/14 | estrogens, conjugated; medroxyprogesterone acetate | TABLET;ORAL-28 | 020527-002 | Nov 17, 1995 | 5,210,081 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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