Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019383
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROVENTIL | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 07/13/1987 | 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 |
|---|---|---|---|---|---|
| 04/09/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/18/1997 | SUPPL-11 | Efficacy-New Indication |
Label is not available on this site. |
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| 11/06/1998 | SUPPL-10 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17559-S023_Proventil.pdf |
| 05/24/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/27/1993 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/12/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/05/1992 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/24/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |