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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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Paddock Laboratories, Inc. - Citizen Petition FDA-2002-P-0381 · 4 docket documents Paddock Laboratories, Inc. filed this citizen petition on September 5, 2002, requesting that the FDA immediately advise sponsors of unapproved ammonium lactate 12% lotion and cream products from Upsher-Smith Laboratories, Clay-Park Laboratories, and SDR Pharmaceuticals that these products are unappr	505(q)	2010-08-09	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

5 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis NCT00990561	Phase 4	Completed	University of California, San Francisco	40	2009-07 → 2010-06
The Effects of Urinary pH Changes on an Investigational Compound in Healthy Subjects NCT01440478	Phase 1	Completed	Eli Lilly and Company	30	2011-09 → 2011-10
Effectiveness of Enhanced Terminal Room Disinfection to Prevent Healthcare-associated Infections (HAIs)NCT01579370	N/A	Completed	Duke University	21,395	2012-04 → 2015-08
Arterial pH and Total Body Nitrogen Balances in APD NCT00586131	Phase 4	Completed	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	8	2003-09 → 2008-04
Airway Responsiveness in Patients With AECOPD Mechanical Ventilation by Inspiratory and Bronchial Dilation Testchronic Obstructive Pulmonary Disease NCT02592122	N/A	UNKNOWN	snow	120	2013-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain4 active DMFs1 inactive

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

PURAC BIOCHEM BVInactiveAMMONIUM LACTATE, PURASAL NH 70

DMF 110751994

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.