Viewing data from:

LOPERAMIDE HYDROCHLORIDE

ANDA

LOPERAMIDE HYDROCHLORIDE | A075232 | L PERRIGO CO

1 strength0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs4 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVLOPERAMIDE HYDROCHLORIDE

DMF 73401988

PMC ISOCHEMLOPERAMIDE HYDROCHLORIDE

DMF 74531988

OLON SPALOPERAMIDE HYDROCHLORIDE

DMF 100281992

OLON SPALOPERAMIDE HYDROCHLORIDE

DMF 105171993

VASUDHA PHARMA CHEM LTDLOPERAMIDE HYDROCHLORIDE USP

DMF 277312013

VAMSI LABS LTDLOPERAMIDE HYDROCHLORIDE USP

DMF 425912025

SIFAVITOR SPAInactiveLOPERAMIDE HYDROCHLORIDE

DMF 72991988

SIPSY CHIMIE FINE SCAInactiveLOPERAMIDE HYDROCHLORIDE

DMF 80511989

LANZ LABORATORIESInactiveLOPERAMIDE HYDROCHLORIDE

DMF 83141989

JANSSEN PHARMACEUTICA NVInactiveLOPERAMIDE HYDROCHLORIDE

DMF 109421994

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 6, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 6, 2000

No patent or exclusivity listings for this strength.