Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075371
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DACARBAZINE DACARBAZINE 100MG/VIAL INJECTABLE;INJECTION Prescription None No Yes
DACARBAZINE DACARBAZINE 200MG/VIAL 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
08/27/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75371ltr.pdf

DACARBAZINE

INJECTABLE;INJECTION; 200MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DACARBAZINE DACARBAZINE 200MG/VIAL INJECTABLE;INJECTION Prescription No AP 075371 FRESENIUS KABI USA
DACARBAZINE DACARBAZINE 200MG/VIAL INJECTABLE;INJECTION Prescription No AP 075940 HOSPIRA
DACARBAZINE DACARBAZINE 200MG/VIAL INJECTABLE;INJECTION Prescription No AP 075259 TEVA PHARMS USA
DACARBAZINE DACARBAZINE 200MG/VIAL INJECTABLE;INJECTION Prescription No AP 075812 WEST-WARD PHARMS INT

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