Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017601
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.

04/20/1992 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1989 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

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.

07/08/1986 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1982 SUPPL-6 Labeling

Label is not available on this site.

03/28/1980 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/15/1980 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/08/1980 SUPPL-3 Labeling

Label is not available on this site.

07/12/1979 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1979 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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