Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076657
Company: TEVA PHARMS USA
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 Yes
IFOSFAMIDE IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/04/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2015 SUPPL-25 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf
05/14/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf
05/14/2015 SUPPL-17 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf
06/13/2014 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/14/2015 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf
05/14/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf
05/14/2015 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf

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 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 076657 TEVA PHARMS USA
IFOSFAMIDE IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 076619 WEST-WARD PHARMS INT

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