Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064117
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MITOMYCIN MITOMYCIN 5MG/VIAL INJECTABLE;INJECTION Discontinued None No No
MITOMYCIN MITOMYCIN 20MG/VIAL INJECTABLE;INJECTION Prescription AP No No
MITOMYCIN MITOMYCIN 40MG/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
04/19/1995 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
07/17/2000 SUPPL-5 Labeling

Label is not available on this site.

06/02/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/02/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/02/1999 SUPPL-2 Labeling

Label is not available on this site.

06/02/1999 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

MITOMYCIN

INJECTABLE;INJECTION; 20MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MITOMYCIN MITOMYCIN 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 064144 ACCORD HLTHCARE
MITOMYCIN MITOMYCIN 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 202670 RK PHARMA
MITOMYCIN MITOMYCIN 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 064117 WEST-WARD PHARMS INT
MITOMYCIN MITOMYCIN 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 064180 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 40MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MITOMYCIN MITOMYCIN 40MG/VIAL INJECTABLE;INJECTION Prescription No AP 064144 ACCORD HLTHCARE
MITOMYCIN MITOMYCIN 40MG/VIAL INJECTABLE;INJECTION Prescription No AP 203386 RK PHARMA
MITOMYCIN MITOMYCIN 40MG/VIAL INJECTABLE;INJECTION Prescription No AP 064117 WEST-WARD PHARMS INT

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