Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200645
Company: ALEMBIC PHARMS LTD
Company: ALEMBIC PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/30/2010 | 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 |
|---|---|---|---|---|---|
| 03/21/2024 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/17/2011 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |