Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085456
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 1.5MG 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
02/08/1977 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/17/1996 SUPPL-20 Labeling

Label is not available on this site.

02/09/1994 SUPPL-19 Labeling

Label is not available on this site.

12/31/1990 SUPPL-18 Labeling

Label is not available on this site.

06/15/1990 SUPPL-17 Labeling

Label is not available on this site.

08/12/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/02/1990 SUPPL-13 Labeling

Label is not available on this site.

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