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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064144
Company: ACCORD HLTHCARE

Products on ANDA 064144

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MITOMYCIN	MITOMYCIN	5MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
MITOMYCIN	MITOMYCIN	40MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064144

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64144ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2023	SUPPL-21	Labeling-Container/Carton Labels		Label is not available on this site.
07/11/2011	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/02/2009	SUPPL-7	Labeling		Label is not available on this site.
08/11/2009	SUPPL-6	Labeling		Label is not available on this site.
08/11/2009	SUPPL-5	Efficacy-New Dosing Regimen		Label is not available on this site.
04/01/2009	SUPPL-4	Labeling		Label is not available on this site.
02/28/2001	SUPPL-2	Labeling		Label is not available on this site.
02/22/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064144

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	216732	EUGIA PHARMA
MITOMYCIN	MITOMYCIN	5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211269	FRESENIUS KABI USA
MITOMYCIN	MITOMYCIN	5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215687	GLAND PHARMA LTD
MITOMYCIN	MITOMYCIN	5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	064180	HIKMA
MITOMYCIN	MITOMYCIN	5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	214505	MEITHEAL
MITOMYCIN	MITOMYCIN	5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202670	RK PHARMA

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	216732	EUGIA PHARMA
MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211269	FRESENIUS KABI USA
MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215687	GLAND PHARMA LTD
MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	064117	HIKMA
MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	064180	HIKMA
MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	214505	MEITHEAL
MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202670	RK PHARMA

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	216732	EUGIA PHARMA
MITOMYCIN	MITOMYCIN	40MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211269	FRESENIUS KABI USA
MITOMYCIN	MITOMYCIN	40MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	216648	GLAND PHARMA LTD
MITOMYCIN	MITOMYCIN	40MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	064117	HIKMA
MITOMYCIN	MITOMYCIN	40MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	214504	MEITHEAL
MITOMYCIN	MITOMYCIN	40MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203386	RK PHARMA

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