Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215636
Company: ZYDUS LIFESCIENCES

Products on ANDA 215636

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLENE BLUE	METHYLENE BLUE	10MG/2ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
METHYLENE BLUE	METHYLENE BLUE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215636

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/05/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215636Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 215636

METHYLENE BLUE

SOLUTION;INTRAVENOUS; 10MG/2ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLENE BLUE	METHYLENE BLUE	10MG/2ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215636	ZYDUS LIFESCIENCES
PROVAYBLUE	METHYLENE BLUE	10MG/2ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204630	PROVEPHARM SAS

SOLUTION;INTRAVENOUS; 50MG/10ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLENE BLUE	METHYLENE BLUE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215636	ZYDUS LIFESCIENCES
PROVAYBLUE	METHYLENE BLUE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204630	PROVEPHARM SAS