Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011418
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIMETANE-TEN BROMPHENIRAMINE MALEATE 10MG/ML INJECTABLE;INJECTION 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
09/29/1958 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
06/03/1992 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1988 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1986 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1984 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1981 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1981 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1980 SUPPL-17 Labeling

Label is not available on this site.

02/01/1980 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1979 SUPPL-15 Labeling

Label is not available on this site.

06/26/1979 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1978 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1978 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1977 SUPPL-11 Labeling

Label is not available on this site.

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