Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075259
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DACARBAZINE DACARBAZINE 500MG/VIAL INJECTABLE;INJECTION Prescription AP No Yes
DACARBAZINE DACARBAZINE 200MG/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
08/27/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75259ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/2000 SUPPL-2 Labeling

Label is not available on this site.

09/22/2000 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

DACARBAZINE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DACARBAZINE DACARBAZINE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 075259 TEVA PHARMS USA
DACARBAZINE DACARBAZINE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 075812 WEST-WARD PHARMS INT

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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