Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080399
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 0.75MG 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
10/20/1971 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
01/20/1984 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

07/27/1983 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

08/03/1982 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

09/27/1982 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

09/27/1982 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

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