Orange Book product · Generic (ANDA)
SCOPOLAMINE
SCOPOLAMINE
At a glance
Nov 24, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 24, 2020
5 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
SCOPOLAMINE
Strength
1MG/72HR
Dosage form
SYSTEM
Route
TRANSDERMAL
TE code
AB
Application
ANDA 212342
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of SCOPOLAMINE
- —TRANSDERM SCOPBrand (NDA)
NDA 017874 · BAXTER HLTHCARE CORP
- 2025SCOPOLAMINEGeneric (ANDA)
ANDA 218384 · AMNEAL
- 2024SCOPOLAMINEGeneric (ANDA)
ANDA 217893 · ZYDUS PHARMS
- 2024SCOPOLAMINEGeneric (ANDA)
ANDA 215329 · RHODES PHARMS
- 2022SCOPOLAMINEGeneric (ANDA)
ANDA 208769 · ACTAVIS LABS UT INC
- 2019SCOPOLAMINEGeneric (ANDA)
ANDA 203753 · MYLAN TECHNOLOGIES
- 2015SCOPOLAMINEGeneric (ANDA)
ANDA 078830 · PADAGIS US
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.
