Details for New Drug Application (NDA): 209866
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NDA 209866 describes PINDOLOL, which is a drug marketed by Ani Pharms, Aurobindo Pharma Usa, Cosette, Mylan Pharms Inc, Nostrum Labs, Nostrum Labs Inc, Purepac Pharm, Sun Pharm Industries, Unichem, Watson Labs, and Zydus Pharms, and is included in fourteen NDAs. It is available from ten 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the pindolol profile page.
Summary for 209866
| Tradename: | PINDOLOL |
| Applicant: | Zydus Pharms |
| Ingredient: | pindolol |
| Patents: | 0 |
Pharmacology for NDA: 209866
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 209866
Suppliers and Packaging for NDA: 209866
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PINDOLOL | pindolol | TABLET;ORAL | 209866 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1063 | 70710-1063-1 | 100 TABLET in 1 BOTTLE (70710-1063-1) |
| PINDOLOL | pindolol | TABLET;ORAL | 209866 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1064 | 70710-1064-1 | 100 TABLET in 1 BOTTLE (70710-1064-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 18, 2017 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 18, 2017 | TE: | RLD: | No | |||||
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