Details for New Drug Application (NDA): 218302
NDA 218302 describes VARENICLINE TARTRATE, which is a drug marketed by Adaptis, Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Aurobindo Pharma, Dr Reddys, Hetero Labs Ltd Iii, Lupin, Macleods Pharms, Mankind Pharma, Micro Labs, Ne Rx Pharma, Ph Health, Pharmazone, Pharmobedient, Regcon Holdings, Rhodes Pharms, Somerset Theraps Llc, Umedica, Viwit Pharm, and Zydus, and is included in twenty-two NDAs. It is available from twenty-seven suppliers. Additional details are available on the VARENICLINE TARTRATE profile page.
The generic ingredient in VARENICLINE TARTRATE is varenicline tartrate. There is one drug master file entry for this compound. Thirty 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 is one drug master file entry for this compound. Thirty 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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