Drugs@FDA: FDA-Approved Drugs
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROVENTIL | 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 |
|---|---|---|---|---|---|---|---|
| 05/01/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/07/2006 | SUPPL-40 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017559s040_ltr.pdf |
| 12/04/2000 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1998 | SUPPL-23 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17559-S023_Proventil.pdf |
| 09/09/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1986 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/08/1986 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/02/1985 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/02/1985 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/21/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1984 | SUPPL-5 | Efficacy |
Label is not available on this site. |
||
| 12/04/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1981 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/02/1981 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |