Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201785
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/11/2021 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201785Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/23/2024 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
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 |
---|---|---|---|---|---|---|---|---|
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 | 217283 | AVALANCHE PHARM |
VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 201785 | ENDO OPERATIONS |
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 | LEADING PHARMA |
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 | 214255 | MANKIND PHARMA |
VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 202019 | MYLAN |
VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 217115 | SLATE RUN PHARMA |
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 |
---|---|---|---|---|---|---|---|---|
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 | 217283 | AVALANCHE PHARM |
VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 201785 | ENDO OPERATIONS |
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 | LEADING PHARMA |
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 | 214255 | MANKIND PHARMA |
VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 202019 | MYLAN |
VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 217115 | SLATE RUN PHARMA |
VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 216723 | ZYDUS |