Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084282
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription AP 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
07/15/1975 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
10/25/2016 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

07/11/2000 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1999 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/12/1998 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

05/07/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/16/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/05/1995 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/15/1995 SUPPL-35 Labeling

Label is not available on this site.

01/27/1994 SUPPL-34 Labeling

Label is not available on this site.

08/28/1992 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/31/1991 SUPPL-32 Labeling

Label is not available on this site.

10/28/1991 SUPPL-31 Labeling

Label is not available on this site.

06/12/1991 SUPPL-29 Labeling

Label is not available on this site.

10/05/1989 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/12/1991 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/15/1989 SUPPL-26 Labeling

Label is not available on this site.

02/17/1989 SUPPL-25 Labeling

Label is not available on this site.

09/07/1988 SUPPL-24 Labeling

Label is not available on this site.

10/22/1985 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/11/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/11/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/11/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/07/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/17/1983 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/17/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

DEXAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION; EQ 4MG PHOSPHATE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 208689 AMNEAL
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 206781 AUROBINDO PHARMA LTD
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 084916 FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 203129 FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 040803 MYLAN LABS LTD
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 207521 SOMERSET
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 084282 WEST-WARD PHARMS INT

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