Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073272
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 12/28/1995 | 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 |
|---|---|---|---|---|---|
| 10/22/2001 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/18/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/18/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/15/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/22/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/16/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/16/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/22/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |