Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091676
Company: SAGENT PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYTOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription AP No No
OXYTOCIN OXYTOCIN 100USP UNITS/10ML (10USP UNITS/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
07/13/2018 ORIG-1 Approval Not Applicable

Label is not available on this site.

OXYTOCIN

INJECTABLE;INJECTION; 10USP UNITS/ML (10USP UNITS/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYTOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018248 FRESENIUS KABI USA
OXYTOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription No AP 200219 HIKMA FARMACEUTICA
OXYTOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription No AP 091676 SAGENT PHARMS INC
OXYTOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018243 WEST-WARD PHARMS INT
PITOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018261 PAR STERILE PRODUCTS

INJECTABLE;INJECTION; 100USP UNITS/10ML (10USP UNITS/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYTOCIN OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018248 FRESENIUS KABI USA
OXYTOCIN OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription No AP 091676 SAGENT PHARMS INC
OXYTOCIN OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018243 WEST-WARD PHARMS INT
PITOCIN OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018261 PAR STERILE PRODUCTS

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