Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071822
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLDOPA AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METHYLDOPA | 50MG;500MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/08/1988 | 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 |
|---|---|---|---|---|---|
| 12/07/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/19/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/03/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/07/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |