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METHYLENE BLUE

ANDA

METHYLENE BLUE | A215636 | ZYDUS LIFESCIENCES GLOBAL FZE

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: PROVAYBLUE(TE code: AP)

API Supply Chain8 active DMFs2 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

PROVEPHARM SASMETHYLENE BLUE

DMF 267352013

MIKROCHEM SPOL SROMETHYLENE BLUE

DMF 316942017

PHARMAZELL GMBHMETHYLENE BLUE USP

DMF 329002023

MACSEN DRUGSMETHYLENE BLUE USP

DMF 350952020

ICROM SRLMETHYLENE BLUE

DMF 363072021

CHEMCON GMBHMETHYLENE BLUE

DMF 363532022

CHEMWERTH INCMETHYLENE BLUE USP

DMF 366032022

SICHUAN QINGMU PHARMACEUTICAL CO LTDMETHYLENE BLUE

DMF 393412024

LUITPOLD PHARMACEUTICALS INCInactiveMETHYLENE BLUE INJECTION, USP 1%

DMF 152372000

ISO TEX DIAGNOSTICS INCInactiveMETHYLENE BLUE I-125

DMF 176842004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 31, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#001 — 10MG/2ML (5MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Dec 5, 2023

No patent or exclusivity listings for this strength.

#002 — 50MG/10ML (5MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Dec 5, 2023

#003 — 5MG/ML (5MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 2, 2026

#004 — 100MG/10ML (10MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Mar 31, 2026