Details for New Drug Application (NDA): 205415
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NDA 205415 describes PINDOLOL, which is a drug marketed by Ani Pharms, Aurobindo Pharma Usa, Cosette Pharms Nc, Mpp Pharma, Mylan Pharms Inc, Nostrum Labs, Purepac Pharm, Sun Pharm Industries, Unichem, Watson Labs, and Zydus Pharms, and is included in fourteen NDAs. It is available from eight suppliers. Additional details are available on the PINDOLOL profile page.
The generic ingredient in PINDOLOL is pindolol. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the pindolol profile page.
The generic ingredient in PINDOLOL is pindolol. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the pindolol profile page.
Summary for 205415
| Tradename: | PINDOLOL |
| Applicant: | Mpp Pharma |
| Ingredient: | pindolol |
| Patents: | 0 |
Pharmacology for NDA: 205415
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 205415
Suppliers and Packaging for NDA: 205415
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PINDOLOL | pindolol | TABLET;ORAL | 205415 | ANDA | Westminster Pharmaceuticals, LLC | 69367-421 | 69367-421-01 | 100 TABLET in 1 BOTTLE (69367-421-01) |
| PINDOLOL | pindolol | TABLET;ORAL | 205415 | ANDA | Westminster Pharmaceuticals, LLC | 69367-422 | 69367-422-01 | 100 TABLET in 1 BOTTLE (69367-422-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 13, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 13, 2016 | TE: | AB | RLD: | No | ||||
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