Orange Book product · Generic (ANDA)
DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE
At a glance
Nov 01, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 01, 2024
1 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DICYCLOMINE HYDROCHLORIDE
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 214332
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 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
- 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.
