Details for New Drug Application (NDA): 215636

NDA 215636 describes METHYLENE BLUE, which is a drug marketed by Zydus Lifesciences and is included in one NDA. It is available from two suppliers. Additional details are available on the METHYLENE BLUE profile page.

The generic ingredient in METHYLENE BLUE is methylene blue. There are twenty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the methylene blue profile page.

Summary for 215636

Tradename:	METHYLENE BLUE
Applicant:	Zydus Lifesciences
Ingredient:	methylene blue
Patents:	0

Pharmacology for NDA: 215636

Mechanism of Action

Oxidation-Reduction Activity

Medical Subject Heading (MeSH) Categories for 215636

Enzyme Inhibitors

Suppliers and Packaging for NDA: 215636

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	215636	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1837	70710-1837-5	5 VIAL in 1 CARTON (70710-1837-5) / 2 mL in 1 VIAL (70710-1837-1)
METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	215636	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1838	70710-1838-5	5 VIAL in 1 CARTON (70710-1838-5) / 10 mL in 1 VIAL (70710-1838-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	10MG/2ML (5MG/ML)
Approval Date:	Dec 5, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/10ML (5MG/ML)
Approval Date:	Dec 5, 2023	TE:	AP	RLD:	No

Complete Access Available with Subscription