Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084754
Company: ANIMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 0.5MG/5ML ELIXIR;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/21/1976 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
10/02/2000 SUPPL-51 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/27/1995 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

06/02/1995 SUPPL-47 Labeling

Label is not available on this site.

05/25/1994 SUPPL-45 Labeling

Label is not available on this site.

07/20/1992 SUPPL-44 Labeling

Label is not available on this site.

05/31/1991 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

05/02/1991 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

01/04/1990 SUPPL-39 Labeling

Label is not available on this site.

10/28/1991 SUPPL-38 Labeling

Label is not available on this site.

04/05/1990 SUPPL-37 Labeling

Label is not available on this site.

02/08/1989 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/28/1989 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/13/1988 SUPPL-32 Labeling

Label is not available on this site.

09/01/1982 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/08/1982 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

DEXAMETHASONE

ELIXIR;ORAL; 0.5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXAMETHASONE DEXAMETHASONE 0.5MG/5ML ELIXIR;ORAL Prescription No AA 084754 ANIMA
DEXAMETHASONE DEXAMETHASONE 0.5MG/5ML ELIXIR;ORAL Prescription No AA 091188 LANNETT CO INC
DEXAMETHASONE DEXAMETHASONE 0.5MG/5ML ELIXIR;ORAL Prescription No AA 090891 LYNE
DEXAMETHASONE DEXAMETHASONE 0.5MG/5ML ELIXIR;ORAL Prescription No AA 088254 WOCKHARDT BIO AG

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