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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216648
Company: GLAND PHARMA LTD

Products on ANDA 216648

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216648

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216648

MITOMYCIN

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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