Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072052
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | EQ 12.5MG BASE;5MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/16/1988 | 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 |
|---|---|---|---|---|---|
| 01/17/2023 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2021 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/08/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/24/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |