Orange Book product · Generic (ANDA)
METHYLENE BLUE
METHYLENE BLUE
At a glance
Feb 02, 2026
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 02, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
METHYLENE BLUE
Strength
5MG/ML (5MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 215636
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of METHYLENE BLUE
- 2019PROVAYBLUEBrand (NDA)
NDA 204630 · PROVEPHARM SAS
- 2025METHYLENE BLUEGeneric (ANDA)
ANDA 219550 · CHENGDU SHUODE
- 2025METHYLENE BLUEGeneric (ANDA)
ANDA 219363 · XIROMED
- 2025METHYLENE BLUEGeneric (ANDA)
ANDA 217380 · MEITHEAL
- 2024METHYLENE BLUEGeneric (ANDA)
ANDA 216959 · HIKMA
- 2024METHYLENE BLUEGeneric (ANDA)
ANDA 216955 · STERISCIENCE
- 2024METHYLENE BLUEGeneric (ANDA)
ANDA 217561 · NEXUS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
