Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088481
Company: FERA PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 6MG TABLET;ORAL Prescription BP No No
DEXAMETHASONE DEXAMETHASONE 0.5MG TABLET;ORAL Prescription BP No No
DEXAMETHASONE DEXAMETHASONE 0.75MG TABLET;ORAL Prescription BP No No
DEXAMETHASONE DEXAMETHASONE 4MG TABLET;ORAL Prescription BP 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
12/15/1983 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
07/24/2008 SUPPL-22 Labeling

Label is not available on this site.

12/06/2002 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/26/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/12/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/30/1995 SUPPL-16 Labeling

Label is not available on this site.

04/28/1994 SUPPL-15 Labeling

Label is not available on this site.

04/29/1992 SUPPL-14 Labeling

Label is not available on this site.

09/18/1990 SUPPL-13 Labeling

Label is not available on this site.

01/23/1990 SUPPL-12 Labeling

Label is not available on this site.

07/31/1989 SUPPL-11 Labeling

Label is not available on this site.

09/16/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/01/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/01/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/26/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/26/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DEXAMETHASONE

There are no Therapeutic Equivalents.

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