Orange Book product · Generic (ANDA)
METHYLENE BLUE
METHYLENE BLUE
At a glance
Nov 22, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 22, 2024
1 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
METHYLENE BLUE
Strength
50MG/10ML (5MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 216955
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METHYLENE BLUE
- 2019PROVAYBLUEBrand (NDA)
NDA 204630 · PROVEPHARM SAS
- 2026METHYLENE BLUEGeneric (ANDA)
ANDA 215636 · ZYDUS LIFESCIENCES
- 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 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.
