Orange Book product · Generic (ANDA)
DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE
At a glance
Apr 23, 2021
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 23, 2021
5 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
DICYCLOMINE HYDROCHLORIDE
Strength
10MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
AA
Application
ANDA 214721
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 217531 · PRINSTON INC
- 2023DICYCLOMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217916 · BIONPHARMA
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.
