Orange Book product · Brand (NDA)
IMODIUM MULTI-SYMPTOM RELIEF
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
At a glance
Nov 30, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 30, 2000
25 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Strength
2MG;125MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021140
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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
- 2002LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEGeneric (ANDA)
ANDA 076029 · PERRIGO
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.
