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Details for New Drug Application (NDA): 076962
NDA 076962 describes BROMOCRIPTINE MESYLATE, which is a drug marketed by Lek Pharm, Mylan, Zydus Pharms Usa Inc, Paddock Llc, and Sandoz Inc, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the BROMOCRIPTINE MESYLATE profile page.
The generic ingredient in BROMOCRIPTINE MESYLATE is bromocriptine mesylate. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.
The generic ingredient in BROMOCRIPTINE MESYLATE is bromocriptine mesylate. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.
Summary for 076962
| Tradename: | BROMOCRIPTINE MESYLATE |
| Applicant: | Mylan |
| Ingredient: | bromocriptine mesylate |
| Patents: | 0 |
| Therapeutic Class: | Antiparkinson Agents Hormonal Agents, Suppressant (Pituitary) |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076962
| Ingredient-type | Ergolines |
Medical Subject Heading (MeSH) Categories for 076962
Suppliers and Packaging for NDA: 076962
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BROMOCRIPTINE MESYLATE | bromocriptine mesylate | TABLET;ORAL | 076962 | ANDA | KAISER FOUNDATION HOSPITALS | 0179-0165 | N | 0179-0165-70 |
| BROMOCRIPTINE MESYLATE | bromocriptine mesylate | TABLET;ORAL | 076962 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2042 | N | 0378-2042-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Sep 24, 2004 | TE: | AB | RLD: | No | ||||
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