An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216959
Company: HIKMA

Products on ANDA 216959

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216959

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216959

METHYLENE BLUE

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	216959	HIKMA
METHYLENE BLUE	METHYLENE BLUE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217380	MEITHEAL
METHYLENE BLUE	METHYLENE BLUE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217561	NEXUS
METHYLENE BLUE	METHYLENE BLUE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216955	STERISCIENCE
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

Top