Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202517
Company: TORRENT
Company: TORRENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | EQ 5MG BASE;40MG | TABLET;ORAL | Discontinued | None | No | No |
TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | EQ 10MG BASE;40MG | TABLET;ORAL | Discontinued | None | No | No |
TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | EQ 5MG BASE;80MG | TABLET;ORAL | Discontinued | None | No | No |
TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | EQ 10MG BASE;80MG | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
01/08/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202517Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/20/2021 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
10/20/2021 | SUPPL-4 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
11/30/2015 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
06/20/2014 | SUPPL-2 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202517Orig1s002ltr.pdf |