Details for New Drug Application (NDA): 216568
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NDA 216568 describes NEBIVOLOL HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Indchemie Health, Macleods Pharms Ltd, Mankind Pharma, MSN, Prinston Inc, Regcon Holdings, Reyoung, Torrent, Unichem, and Watson Labs Inc, and is included in eighteen NDAs. It is available from twenty-three 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-four 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-four suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.
Summary for 216568
| Tradename: | NEBIVOLOL HYDROCHLORIDE |
| Applicant: | Regcon Holdings |
| Ingredient: | nebivolol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216568
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 216568
Suppliers and Packaging for NDA: 216568
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 216568 | ANDA | Apnar Pharma LP | 24689-159 | 24689-159-01 | 30 TABLET in 1 BOTTLE (24689-159-01) |
| NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 216568 | ANDA | Apnar Pharma LP | 24689-159 | 24689-159-02 | 90 TABLET in 1 BOTTLE (24689-159-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Mar 30, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Mar 30, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Mar 30, 2023 | TE: | AB | RLD: | No | ||||
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