Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 002386
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOPHYLLIN AMINOPHYLLINE 100MG TABLET;ORAL Discontinued None No No
AMINOPHYLLIN AMINOPHYLLINE 200MG 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
04/19/1940 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
08/27/1991 SUPPL-15 Labeling

Label is not available on this site.

08/14/1989 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/27/1991 SUPPL-13 Labeling

Label is not available on this site.

08/27/1991 SUPPL-12 Labeling

Label is not available on this site.

12/09/1983 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1981 SUPPL-10 Labeling

Label is not available on this site.

04/14/1981 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/23/1980 SUPPL-8 Labeling

Label is not available on this site.

06/13/1980 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1980 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1980 SUPPL-5 Labeling

Label is not available on this site.

01/18/1980 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1977 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1977 SUPPL-2 Labeling

Label is not available on this site.

08/01/1977 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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