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Last Updated: November 21, 2024

AMMONIUM LACTATE - Generic Drug Details


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What are the generic drug sources for ammonium lactate and what is the scope of freedom to operate?

Ammonium lactate is the generic ingredient in two branded drugs marketed by Padagis Israel, Taro, Watson Labs Inc, and Sun Pharm Inds Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for ammonium lactate. Five suppliers are listed for this compound.

Summary for AMMONIUM LACTATE
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Drug Sales Revenue Trends for AMMONIUM LACTATE

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Recent Clinical Trials for AMMONIUM LACTATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Indonesia UniversityPhase 3
University of California, San FranciscoPhase 4
Onset TherapeuticsPhase 4

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Pharmacology for AMMONIUM LACTATE
Mechanism of ActionAcidifying Activity

US Patents and Regulatory Information for AMMONIUM LACTATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro AMMONIUM LACTATE ammonium lactate LOTION;TOPICAL 076216-001 May 28, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Inc LAC-HYDRIN ammonium lactate LOTION;TOPICAL 019155-001 Apr 24, 1985 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taro AMMONIUM LACTATE ammonium lactate CREAM;TOPICAL 075883-001 Apr 10, 2003 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs Inc AMMONIUM LACTATE ammonium lactate CREAM;TOPICAL 076829-001 Feb 7, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Inc LAC-HYDRIN ammonium lactate CREAM;TOPICAL 020508-001 Aug 29, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Padagis Israel AMMONIUM LACTATE ammonium lactate CREAM;TOPICAL 075774-001 May 1, 2002 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs Inc AMMONIUM LACTATE ammonium lactate LOTION;TOPICAL 075575-001 Jun 11, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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