Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201586
Company: LUPIN
Company: LUPIN
| 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 | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201586Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/07/2019 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/02/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/02/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |