Details for New Drug Application (NDA): 020664
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The generic ingredient in DOSTINEX is cabergoline. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cabergoline profile page.
Summary for 020664
Tradename: | DOSTINEX |
Applicant: | Pfizer |
Ingredient: | cabergoline |
Patents: | 0 |
Suppliers and Packaging for NDA: 020664
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOSTINEX | cabergoline | TABLET;ORAL | 020664 | NDA AUTHORIZED GENERIC | Greenstone LLC | 59762-1005 | 59762-1005-1 | 8 TABLET in 1 BOTTLE (59762-1005-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 23, 1996 | TE: | RLD: | Yes |
Expired US Patents for NDA 020664
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | DOSTINEX | cabergoline | TABLET;ORAL | 020664-001 | Dec 23, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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