Details for New Drug Application (NDA): 214557
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NDA 214557 describes VARENICLINE TARTRATE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Bionpharma, Dr Reddys, Endo Operations, Hetero Labs Ltd Iii, Indoco, Leading Pharma, Lupin Ltd, Mankind Pharma, Mylan, Piramal, and Zydus, and is included in fourteen NDAs. It is available from twenty-three suppliers. Additional details are available on the VARENICLINE TARTRATE profile page.
The generic ingredient in VARENICLINE TARTRATE is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
The generic ingredient in VARENICLINE TARTRATE is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
Summary for 214557
| Tradename: | VARENICLINE TARTRATE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | varenicline tartrate |
| Patents: | 0 |
Pharmacology for NDA: 214557
| Mechanism of Action | Cholinergic Agonists Partial Cholinergic Nicotinic Agonists |
Medical Subject Heading (MeSH) Categories for 214557
Suppliers and Packaging for NDA: 214557
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 214557 | ANDA | Major Pharmaceuticals | 0904-7413 | 0904-7413-35 | 56 TABLET, FILM COATED in 1 BOTTLE (0904-7413-35) |
| VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 214557 | ANDA | Major Pharmaceuticals | 0904-7414 | 0904-7414-35 | 56 TABLET, FILM COATED in 1 BOTTLE (0904-7414-35) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Aug 23, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Aug 23, 2023 | TE: | AB | RLD: | No | ||||
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