FDA Orange Book · active-ingredient family
Ammonium lactate
Ammonium lactate: 2 brands, 8 generics; first approved Apr 24, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
8
Listed patents
0
Presentations
10
Brand (NDA) products
Originator applications
- LAC-HYDRINRLDSUN PHARM INDS INCNDA 0205081996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12% BASE CREAM TOPICAL Discontinued — - LAC-HYDRINRLDSUN PHARM INDS INCNDA 0191551985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12% BASE LOTION TOPICAL Discontinued —
Generic (ANDA) products (8)
Abbreviated applications
- AMMONIUM LACTATEZYDUS LIFESCIENCESANDA 2177582026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12% BASE LOTION TOPICAL Rx AB - AMMONIUM LACTATEZYDUS LIFESCIENCESANDA 2178152026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12% BASE CREAM TOPICAL Rx AB - AMMONIUM LACTATEWATSON LABS INCANDA 0768292006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12% BASE CREAM TOPICAL Discontinued — - AMMONIUM LACTATERSPADAGIS ISRAELANDA 0755702004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12% BASE LOTION TOPICAL Rx AB - AMMONIUM LACTATESUN PHARMA CANADAANDA 0762162004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12% BASE LOTION TOPICAL Rx AB - AMMONIUM LACTATERSSUN PHARMA CANADAANDA 0758832003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12% BASE CREAM TOPICAL Rx AB - AMMONIUM LACTATEWATSON LABS INCANDA 0755752002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12% BASE LOTION TOPICAL Discontinued — - AMMONIUM LACTATEPADAGIS ISRAELANDA 0757742002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12% BASE CREAM TOPICAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
41 yr 11 mo ago
Most recent approval
3 mo ago
Approvals span 1985–2026 across 10 FDA applications.
Brand (NDA) 220%
Generic (ANDA) 880%
Ammonium lactate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
