Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077137
Company: CIPLA
Company: CIPLA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | EQ 250MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 07/02/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077137s000_ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/09/2021 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/09/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/10/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |