Details for New Drug Application (NDA): 218302
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NDA 218302 describes VARENICLINE TARTRATE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Aurobindo Pharma, Dr Reddys, Hetero Labs Ltd Iii, Kanchan Hlthcare, Lupin, Macleods Pharms Ltd, Mankind Pharma, Micro Labs, Ne Rx Pharma, Ph Health, Pharmobedient, Piramal, Regcon Holdings, Rhodes Pharms, Shilpa, Umedica, Viwit Pharm, and Zydus, and is included in twenty-one NDAs. It is available from twenty-nine 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. Thirty-three 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. Thirty-three suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
Summary for 218302
| Tradename: | VARENICLINE TARTRATE |
| Applicant: | Micro Labs |
| Ingredient: | varenicline tartrate |
| Patents: | 0 |
Pharmacology for NDA: 218302
| Mechanism of Action | Cholinergic Agonists Partial Cholinergic Nicotinic Agonists |
Medical Subject Heading (MeSH) Categories for 218302
Suppliers and Packaging for NDA: 218302
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 218302 | ANDA | Micro Labs Limited | 42571-459 | 42571-459-82 | 56 TABLET, FILM COATED in 1 BOTTLE (42571-459-82) |
| VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 218302 | ANDA | Micro Labs Limited | 42571-460 | 42571-460-82 | 56 TABLET, FILM COATED in 1 BOTTLE (42571-460-82) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Oct 29, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Oct 29, 2025 | TE: | AB | RLD: | No | ||||
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