Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074947
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/30/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74947ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/29/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/18/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/16/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/09/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/03/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/31/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/11/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/03/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |