Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074749
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 01/30/1998 | 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 |
|---|---|---|---|---|---|
| 09/25/2017 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/2001 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/21/2001 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/21/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/2001 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/04/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/04/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |