Viewing data from:

AMMONIUM LACTATE

ANDA

AMMONIUM LACTATE | A075570 | PADAGIS ISRAEL PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.0699

per gm

Lowest NADAC/Unit

$0.0673

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
45802041926AMMONIUM LACTATE 12% LOTION	$0.0699	GM	Generic	—	2026-06-17
45802041954AMMONIUM LACTATE 12% LOTION	$0.0673	GM	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

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.

Products (1)

#001 — EQ 12% BASE

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Jun 23, 2004

No patent or exclusivity listings for this strength.