Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065221
Company: HIKMA INTL PHARMS
Company: HIKMA INTL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIFAMPIN AND ISONIAZID | ISONIAZID; RIFAMPIN | 150MG;300MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/2005 | 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 |
|---|---|---|---|---|---|
| 08/16/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/03/2023 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |