Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016030
Company: BAYER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
8-HOUR BAYER ASPIRIN 650MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
MEASURIN ASPIRIN 650MG 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
06/25/1965 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
10/25/1995 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1994 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1991 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

09/17/1990 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

09/23/1987 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

09/23/1987 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/20/1986 SUPPL-37 Labeling

Label is not available on this site.

06/20/1986 SUPPL-36 Labeling

Label is not available on this site.

06/20/1986 SUPPL-35 Labeling

Label is not available on this site.

06/20/1986 SUPPL-34 Labeling

Label is not available on this site.

02/04/1985 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/16/1984 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/25/1983 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/09/1983 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/14/1983 SUPPL-29 Labeling

Label is not available on this site.

01/11/1983 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/08/1983 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/07/1983 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/06/1982 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/17/1980 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/28/1980 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1979 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/24/1979 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/02/1979 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/12/1975 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

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