Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091546
Company: SUN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL 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
07/26/2011 ORIG-1 Approval

Label is not available on this site.

CHLOROTHIAZIDE SODIUM

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202561 AM REGENT
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090896 FRESENIUS KABI USA
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202493 MYLAN INSTITUTIONAL
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202462 SAGENT PHARMS INC
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091546 SUN PHARM
DIURIL CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 011145 OAK PHARMS AKORN

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