Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088254
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 0.5MG/5ML ELIXIR;ORAL Prescription AA 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
07/27/1983 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
02/06/2015 SUPPL-15 Labeling

Label is not available on this site.

02/03/1995 SUPPL-13 Labeling

Label is not available on this site.

12/23/1993 SUPPL-12 Labeling

Label is not available on this site.

12/23/1993 SUPPL-11 Labeling

Label is not available on this site.

12/31/1990 SUPPL-10 Labeling

Label is not available on this site.

12/06/1989 SUPPL-9 Labeling

Label is not available on this site.

05/18/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/18/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/22/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/08/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/22/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/01/1984 SUPPL-1 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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