Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218985
Company: UMEDICA
Company: UMEDICA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/09/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
VARENICLINE TARTRATE
TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHANTIX | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021928 | PF PRISM CV |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 213019 | AJANTA PHARMA LTD |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 214557 | ALKEM LABS LTD |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 201962 | APOTEX |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 214595 | AUROBINDO PHARMA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 215931 | DR REDDYS |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 214571 | HETERO LABS LTD III |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 217151 | KANCHAN HLTHCARE |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 211862 | LUPIN LTD |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 215048 | MACLEODS PHARMS LTD |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 214255 | MANKIND PHARMA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 218302 | MICRO LABS |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 217283 | NE RX PHARMA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 201785 | PH HEALTH |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 202019 | PHARMOBEDIENT |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 217115 | PIRAMAL |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 219106 | REGCON HOLDINGS |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 216615 | SHILPA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 218985 | UMEDICA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 212879 | VIWIT PHARM |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 216723 | ZYDUS |
TABLET;ORAL; EQ 1MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHANTIX | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021928 | PF PRISM CV |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 213019 | AJANTA PHARMA LTD |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 214557 | ALKEM LABS LTD |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 201962 | APOTEX |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 214595 | AUROBINDO PHARMA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 215931 | DR REDDYS |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 214571 | HETERO LABS LTD III |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 217151 | KANCHAN HLTHCARE |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 211862 | LUPIN LTD |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 215048 | MACLEODS PHARMS LTD |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 214255 | MANKIND PHARMA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 218302 | MICRO LABS |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 217283 | NE RX PHARMA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 201785 | PH HEALTH |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 202019 | PHARMOBEDIENT |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 217115 | PIRAMAL |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 219106 | REGCON HOLDINGS |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 216615 | SHILPA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 218985 | UMEDICA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 212879 | VIWIT PHARM |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 216723 | ZYDUS |