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, Bayshore Pharms Llc, Cosette, Mylan Pharms Inc, Nostrum Labs, Nostrum Labs Inc, Purepac Pharm, Sun Pharm Industries, Watson Labs, and Zydus Pharms, and is included in fourteen NDAs. It is available from nine suppliers. Additional details are available on the PINDOLOL profile page.
The generic ingredient in PINDOLOL is pindolol. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the pindolol profile page.
The generic ingredient in PINDOLOL is pindolol. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the pindolol profile page.
Summary for 205415
| Tradename: | PINDOLOL |
| Applicant: | Nostrum Labs Inc |
| 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 | Nostrum Laboratories, Inc. | 29033-028 | 29033-028-01 | 100 TABLET in 1 BOTTLE (29033-028-01) |
| PINDOLOL | pindolol | TABLET;ORAL | 205415 | ANDA | Nostrum Laboratories, Inc. | 29033-029 | 29033-029-01 | 100 TABLET in 1 BOTTLE (29033-029-01) |
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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