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 | 25MG | 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 |
|---|---|---|---|---|---|
| 05/24/2023 | SUPPL-123 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/02/2016 | SUPPL-122 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-121 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/10/2008 | SUPPL-114 | Labeling |
Label is not available on this site. |
||
| 06/25/2007 | SUPPL-113 | Labeling |
Label is not available on this site. |
||
| 06/15/2005 | SUPPL-112 | Labeling |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-109 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/09/2001 | SUPPL-108 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/16/2001 | SUPPL-107 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-106 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1999 | SUPPL-105 | Labeling |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-104 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1999 | SUPPL-102 | Labeling |
Label is not available on this site. |
||
| 06/01/1999 | SUPPL-101 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/2007 | SUPPL-100 | Labeling |
Label is not available on this site. |
||
| 03/21/1995 | SUPPL-96 | Labeling |
Label is not available on this site. |
||
| 04/06/1995 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1994 | SUPPL-94 | Labeling |
Label is not available on this site. |
||
| 05/15/1989 | SUPPL-93 | Bioequivalence |
Label is not available on this site. |
||
| 06/13/1991 | SUPPL-92 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/1991 | 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. |
||
| 02/22/1988 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1988 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1988 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1986 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/27/1985 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1986 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1986 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1986 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1983 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1983 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1982 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1982 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
IMIPRAMINE HYDROCHLORIDE
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040903 | LEADING |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040751 | OXFORD PHARMS |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 083745 | SANDOZ |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 088262 | STRIDES PHARMA |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 081049 | SUN PHARM INDUSTRIES |