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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215654
Company: GLAND PHARMA LTD

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
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG 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
08/04/2021 ORIG-1 Approval STANDARD

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 EUGIA PHARMA
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription Yes 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 215654 GLAND PHARMA LTD
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 211451 HIKMA
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

INJECTABLE;INJECTION; EQ 10MG 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 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 210966 EUGIA PHARMA
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 210967 EUGIA PHARMA
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 040572 FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 209192 FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 215654 GLAND PHARMA LTD
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 217797 MICRO LABS
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 040802 MYLAN LABS LTD
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 211036 SOMERSET THERAPS LLC
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 087702 WEST-WARD PHARMS INT
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 208690 AMNEAL
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 040491 FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 207442 SOMERSET THERAPS LLC
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