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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216597
Company: AMNEAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription AP No No
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/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
02/15/2023 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/12/2023 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

MAGNESIUM SULFATE IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 2GM/50ML (40MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAGNESIUM SULFATE MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 207967 B BRAUN MEDICAL INC
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 216597 AMNEAL
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 211966 BAXTER HLTHCARE CORP
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 206485 FRESENIUS KABI USA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 213917 GLAND PHARMA LTD
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020309 HOSPIRA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 207350 HQ SPCLT PHARMA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 209642 MILLA PHARMS
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 209911 MYLAN LABS LTD

INJECTABLE;INJECTION; 4GM/100ML (40MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAGNESIUM SULFATE MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 207967 B BRAUN MEDICAL INC
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 216597 AMNEAL
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 211966 BAXTER HLTHCARE CORP
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 206485 FRESENIUS KABI USA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 213917 GLAND PHARMA LTD
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020309 HOSPIRA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 207350 HQ SPCLT PHARMA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 209642 MILLA PHARMS
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 209911 MYLAN LABS LTD
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