Viewing data from:

LAC-HYDRIN

NDA

AMMONIUM LACTATE | N020508 | SUN PHARMACEUTICAL INDUSTRIES INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs

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

INOLEX CHEMICAL COAMMONIUM LACTATE

DMF 51301983

VANAMALI ORGANICS PVT LTDAMMONIUM LACTATE

DMF 120031996

PFANSTIEHL INCAMMONIUM LACTATE

DMF 126121997

CHATTEM CHEMICALS INCAMMONIUM LACTATE

DMF 138431998

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 22, 2004	SUPPL -6	View Letter (PDF)
Aug 25, 2000	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Aug 29, 1996

No patent or exclusivity listings for this strength.