Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020014
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MAXAIR | PIRBUTEROL ACETATE | EQ 0.2MG BASE/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 |
|---|---|---|---|---|---|---|---|
| 11/30/1992 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/27/2006 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020014s022LTR.pdf |
| 11/27/2001 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/17/2001 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/11/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/29/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/26/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/26/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/12/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/11/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 07/24/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 07/29/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/07/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 08/14/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/06/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 02/25/1994 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |