Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081048
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/05/1990 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/02/2016 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2014 | SUPPL-31 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/19/2007 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 10/19/2007 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 06/26/2007 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 12/02/2005 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/05/2005 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/02/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/26/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |