Details for New Drug Application (NDA): 213349
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NDA 213349 describes NEBIVOLOL HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Beximco Pharms Usa, Cadila Pharms Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Indchemie Health, Mankind Pharma, MSN, Prinston Inc, Reyoung, Torrent, Unichem, and Watson Labs Inc, and is included in seventeen NDAs. It is available from twenty-two suppliers. Additional details are available on the NEBIVOLOL HYDROCHLORIDE profile page.
The generic ingredient in NEBIVOLOL HYDROCHLORIDE is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.
The generic ingredient in NEBIVOLOL HYDROCHLORIDE is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.
Summary for 213349
| Tradename: | NEBIVOLOL HYDROCHLORIDE |
| Applicant: | Ajanta Pharma Ltd |
| Ingredient: | nebivolol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 213349
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 213349
Suppliers and Packaging for NDA: 213349
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 213349 | ANDA | Ajanta Pharma USA Inc. | 27241-179 | 27241-179-30 | 30 TABLET in 1 BOTTLE (27241-179-30) |
| NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 213349 | ANDA | Ajanta Pharma USA Inc. | 27241-180 | 27241-180-30 | 30 TABLET in 1 BOTTLE (27241-180-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Mar 31, 2022 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Mar 31, 2022 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Mar 31, 2022 | TE: | RLD: | No | |||||
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