Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064180
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 Prescription AP No No
MITOMYCIN MITOMYCIN 20MG/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
12/23/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/64180ltr.pdf

MITOMYCIN

INJECTABLE;INJECTION; 5MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MITOMYCIN MITOMYCIN 5MG/VIAL INJECTABLE;INJECTION Prescription No AP 064144 ACCORD HLTHCARE
MITOMYCIN MITOMYCIN 5MG/VIAL INJECTABLE;INJECTION Prescription No AP 202670 RK PHARMA
MITOMYCIN MITOMYCIN 5MG/VIAL INJECTABLE;INJECTION Prescription No AP 064180 WEST-WARD PHARMS INT

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

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