Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074072
Company: PLIVA
Company: PLIVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBUTEROL | ALBUTEROL | 0.09MG/INH | AEROSOL, METERED;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 08/01/1996 | 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 |
|---|---|---|---|---|---|
| 08/23/2001 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/20/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/13/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 07/13/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 12/03/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 05/08/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 01/20/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/14/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |