Orange Book product · Brand (NDA)
IMODIUM A-D EZ CHEWS
LOPERAMIDE HYDROCHLORIDE
At a glance
Jul 24, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 1997
29 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
LOPERAMIDE HYDROCHLORIDE
Strength
2MG
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
Not listed
Application
NDA 020448
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.
- 2005LOPERAMIDE HYDROCHLORIDEBrand (NDA)
NDA 021855 · BIONPHARMA
- 1989IMODIUM A-DBrand (NDA)
NDA 019860 · KENVUE BRANDS
- 1988IMODIUM A-DBrand (NDA)
NDA 019487 · KENVUE BRANDS
- 1984IMODIUMBrand (NDA)
NDA 019037 · JANSSEN PHARMS
- —IMODIUMBrand (NDA)
NDA 017690 · J AND J CONSUMER INC
- —IMODIUMBrand (NDA)
NDA 017694 · J AND J CONSUMER INC
- 2025LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 220372 · AUROBINDO PHARMA
- 2025LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 220153 · MARKSANS PHARMA
- 2025LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 220100 · BIONPHARMA
- 2023LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 218122 · AUROBINDO PHARMA LTD
- 2023LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 217840 · JUBILANT CADISTA
- 2023LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 217471 · ZYDUS LIFESCIENCES
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.
