Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017601
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OPTIMINE | AZATADINE MALEATE | 1MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/29/1977 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 11/04/2002 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17601slr020LTR.pdf |
| 03/22/2000 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/20/1992 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/24/1989 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/06/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/01/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1991 | SUPPL-9 | Manufacturing (CMC)-Control |
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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| 02/06/1985 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/25/1982 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/28/1980 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 02/15/1980 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/08/1980 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 07/12/1979 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/22/1979 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |