Orange Book product · Brand (NDA)
PROVAYBLUE
METHYLENE BLUE
At a glance
Jul 18, 2019
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 18, 2019
7 yr ago
Today
Exclusivity ends · M-303
New use / labeling-change exclusivity (3 years)
Jan 08, 2027
in 7 mo
Pharmaceutical detail
Active ingredient
METHYLENE BLUE
Strength
10MG/2ML (5MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 204630
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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 216955 · STERISCIENCE
- 2024METHYLENE BLUEGeneric (ANDA)
ANDA 217561 · NEXUS
Marketing exclusivity (1)
- M-303New use / labeling-change exclusivity (3 years)
Jan 08, 2027
in 7 mo
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.
