Orange Book product · Generic (ANDA)
DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE
At a glance
Aug 30, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 2023
2 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DICYCLOMINE HYDROCHLORIDE
Strength
10MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 217531
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DICYCLOMINE HYDROCHLORIDE
- 1984BENTYLBrand (NDA)
NDA 007409 · ALLERGAN
- 1984BENTYLBrand (NDA)
NDA 008370 · ABBVIE
- 1984BENTYLBrand (NDA)
NDA 007961 · APTALIS PHARMA US
- 2025DICYCLOMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219242 · RISING
- 2025DICYCLOMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218310 · PRINSTON INC
- 2024DICYCLOMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218952 · RISING
- 2024DICYCLOMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214332 · SOMERSET THERAPS LLC
- 2024DICYCLOMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214333 · SOMERSET THERAPS LLC
- 2024DICYCLOMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218018 · ANNORA PHARMA
- 2024DICYCLOMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217566 · ANNORA PHARMA
- 2023DICYCLOMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217916 · BIONPHARMA
- 2023DICYCLOMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216782 · TWI PHARMS
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.
