Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/20/1976 | 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 |
|---|---|---|---|---|---|
| 06/24/2025 | SUPPL-136 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/24/2023 | SUPPL-129 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/02/2016 | SUPPL-128 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-127 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/10/2008 | SUPPL-120 | Labeling |
Label is not available on this site. |
||
| 06/25/2007 | SUPPL-119 | Labeling |
Label is not available on this site. |
||
| 06/15/2005 | SUPPL-118 | Labeling |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-115 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/09/2001 | SUPPL-114 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/16/2001 | SUPPL-113 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-112 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1999 | SUPPL-111 | Labeling |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-110 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1999 | SUPPL-108 | Labeling |
Label is not available on this site. |
||
| 05/01/1999 | SUPPL-107 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/2007 | SUPPL-106 | Labeling |
Label is not available on this site. |
||
| 03/21/1995 | SUPPL-102 | Labeling |
Label is not available on this site. |
||
| 04/06/1995 | SUPPL-101 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1994 | SUPPL-100 | Labeling |
Label is not available on this site. |
||
| 04/15/1991 | SUPPL-99 | Labeling |
Label is not available on this site. |
||
| 11/07/1989 | SUPPL-98 | Labeling |
Label is not available on this site. |
||
| 09/15/1989 | SUPPL-97 | Labeling |
Label is not available on this site. |
||
| 10/02/1990 | SUPPL-96 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1988 | SUPPL-94 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1988 | SUPPL-93 | Labeling |
Label is not available on this site. |
||
| 02/22/1988 | SUPPL-92 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1988 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1988 | SUPPL-90 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1988 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1987 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1986 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1986 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1986 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1986 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1986 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/27/1985 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1983 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1983 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1982 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1982 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1982 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1982 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
IMIPRAMINE HYDROCHLORIDE
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040903 | LEADING |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040751 | OXFORD PHARMS |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 084937 | SANDOZ |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 088276 | STRIDES PHARMA INTL |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 081050 | SUN PHARM INDUSTRIES |