Orange Book product · Generic (ANDA)
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
At a glance
Aug 30, 2002
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 2002
24 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Strength
2MG;125MG
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
Not listed
Application
ANDA 076029
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
- 2000IMODIUM MULTI-SYMPTOM RELIEFBrand (NDA)
NDA 021140 · KENVUE BRANDS
- 1996IMODIUM MULTI-SYMPTOM RELIEFBrand (NDA)
NDA 020606 · J AND J CONSUMER INC
- 2022LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEGeneric (ANDA)
ANDA 215981 · GRANULES
- 2021LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEGeneric (ANDA)
ANDA 213484 · BIONPHARMA
- 2021LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEGeneric (ANDA)
ANDA 211438 · HETERO LABS LTD V
- 2021LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEGeneric (ANDA)
ANDA 214541 · GUARDIAN DRUG
- 2020LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEGeneric (ANDA)
ANDA 211059 · AUROBINDO PHARMA LTD
- 2018LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEGeneric (ANDA)
ANDA 209837 · PERRIGO R AND D
- 2006LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEGeneric (ANDA)
ANDA 077500 · SUN PHARM INDS LTD
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.
