Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203129
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 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
09/30/2015 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
08/09/2016 SUPPL-1 Labeling-Package Insert

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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