Orange Book product · Generic (ANDA)
LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE
At a glance
Oct 06, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 06, 2021
4 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
LOPERAMIDE HYDROCHLORIDE
Strength
2MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 215001
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LOPERAMIDE HYDROCHLORIDE
- 2005LOPERAMIDE HYDROCHLORIDEBrand (NDA)
NDA 021855 · BIONPHARMA
- 1997IMODIUM A-D EZ CHEWSBrand (NDA)
NDA 020448 · J AND J CONSUMER INC
- 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
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.
