Orange Book product · Brand (NDA)
IMODIUM MULTI-SYMPTOM RELIEF
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
At a glance
Jun 26, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 26, 1996
30 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Strength
2MG;125MG
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
Not listed
Application
NDA 020606
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2000IMODIUM MULTI-SYMPTOM RELIEFBrand (NDA)
NDA 021140 · KENVUE BRANDS
- 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.
