Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076619
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IFOSFAMIDE IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription AP No No
IFOSFAMIDE IFOSFAMIDE 3GM/60ML (50MG/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
06/29/2011 ORIG-1 Approval

Label is not available on this site.

IFOSFAMIDE

INJECTABLE;INJECTION; 1GM/20ML (50MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IFOSFAMIDE IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 201689 MYLAN LABS LTD
IFOSFAMIDE IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 076657 TEVA PHARMS USA
IFOSFAMIDE IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 076619 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 3GM/60ML (50MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IFOSFAMIDE IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 201689 MYLAN LABS LTD
IFOSFAMIDE IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 076657 TEVA PHARMS USA
IFOSFAMIDE IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 076619 WEST-WARD PHARMS INT

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