FDA Orange Book · active-ingredient family
Loperamide hydrochloride; simethicone
Loperamide hydrochloride; simethicone is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IMODIUM MULTI-SYMPTOM RELIEF · NDA 021140
2
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, chewable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IMODIUM MULTI-SYMPTOM RELIEFRLD | KENVUE BRANDS | NDA 021140 | — | Nov 30, 2000 | |
| IMODIUM MULTI-SYMPTOM RELIEFRLD | J AND J CONSUMER INC | NDA 020606 | — | Jun 26, 1996 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | GRANULES | ANDA 215981 | — | Aug 29, 2022 | |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | BIONPHARMA | ANDA 213484 | — | Sep 10, 2021 | |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | HETERO LABS LTD V | ANDA 211438 | — | Jun 17, 2021 | |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | GUARDIAN DRUG | ANDA 214541 | — | May 27, 2021 | |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | AUROBINDO PHARMA LTD | ANDA 211059 | — | Dec 14, 2020 | |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | PERRIGO R AND D | ANDA 209837 | — | Sep 05, 2018 | |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | SUN PHARM INDS LTD | ANDA 077500 | — | Sep 06, 2006 | |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | PERRIGO | ANDA 076029 | — | Aug 30, 2002 |
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.
Loperamide hydrochloride; simethicone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
