Orange Book product · Generic (ANDA)
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Generic (ANDA)ANDA 218426TE ABRX HETERO LABS LTD III
At a glance
Aug 28, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 28, 2024
1 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Strength
20MG;10MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 218426
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
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.
