Orange Book product · Generic (ANDA)
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
At a glance
Dec 14, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 14, 2023
2 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Strength
5MG;2.5MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 217385
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
- —LIBRAXBrand (NDA)
NDA 012750 · BAUSCH
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ANDA 212344 · WINDER LABS LLC
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ANDA 216969 · ALEMBIC
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ANDA 216419 · AUROBINDO PHARMA LTD
- 2022CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEGeneric (ANDA)
ANDA 215453 · COREPHARMA
- 2022CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEGeneric (ANDA)
ANDA 215835 · MICRO LABS
- 2021CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEGeneric (ANDA)
ANDA 211476 · TEVA PHARMS USA
- 2021CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEGeneric (ANDA)
ANDA 215555 · AMNEAL
- 2021CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEGeneric (ANDA)
ANDA 214698 · DR REDDYS
- 2021CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEGeneric (ANDA)
ANDA 214065 · ALKEM LABS LTD
- 2020CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEGeneric (ANDA)
ANDA 213530 · CHARTWELL RX
- 2020CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEGeneric (ANDA)
ANDA 210579 · MISEMER
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.
