Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084916
Company: FRESENIUS KABI USA
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 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
09/06/1977 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
07/03/2014 SUPPL-66 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084916s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040491Orig1s008,040572Orig1s002,084916Orig1s066ltr.pdf
12/05/2002 SUPPL-57 Manufacturing (CMC)-Facility

Label is not available on this site.

06/13/2001 SUPPL-56 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/20/1995 SUPPL-54 Labeling

Label is not available on this site.

01/11/1994 SUPPL-53 Labeling

Label is not available on this site.

06/13/1991 SUPPL-52 Labeling

Label is not available on this site.

09/13/1991 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

02/06/1991 SUPPL-50 Labeling

Label is not available on this site.

07/12/1989 SUPPL-48 Labeling

Label is not available on this site.

11/02/1988 SUPPL-47 Labeling

Label is not available on this site.

06/13/1986 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

12/06/1984 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

01/03/1985 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

01/03/1985 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

01/17/1984 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/06/1983 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/19/1982 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/03/2014 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084916s066lbl.pdf

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 PHARMS CO
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 207521 ANDA REPOSITORY
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 084282 WEST-WARD PHARMS INT

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