Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017853
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROVENTIL | ALBUTEROL SULFATE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| PROVENTIL | ALBUTEROL SULFATE | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/07/1982 | 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 |
|---|---|---|---|---|---|
| 08/12/1999 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/06/1998 | SUPPL-16 | 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-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/15/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/24/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/08/1986 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/24/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 12/24/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 12/04/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/16/1986 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 05/24/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |