Details for New Drug Application (NDA): 077646
NDA 077646 describes BROMOCRIPTINE MESYLATE, which is a drug marketed by Lek Pharm, Mylan, Zydus Pharms Usa Inc, Aurobindo Pharma Usa, Padagis Us, and Sandoz, and is included in six NDAs. It is available from six suppliers. Additional details are available on the BROMOCRIPTINE MESYLATE profile page.
The generic ingredient in BROMOCRIPTINE MESYLATE is bromocriptine mesylate. There is one drug master file entry for this compound. Nine 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 is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.
Summary for 077646
| Tradename: | BROMOCRIPTINE MESYLATE |
| Applicant: | Padagis Us |
| Ingredient: | bromocriptine mesylate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077646
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BROMOCRIPTINE MESYLATE | bromocriptine mesylate | TABLET;ORAL | 077646 | ANDA | Padagis US LLC | 0574-0106 | 0574-0106-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0574-0106-01) |
| BROMOCRIPTINE MESYLATE | bromocriptine mesylate | TABLET;ORAL | 077646 | ANDA | Padagis US LLC | 0574-0106 | 0574-0106-03 | 30 TABLET in 1 BOTTLE, PLASTIC (0574-0106-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Oct 1, 2008 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
