FDA Orange Book · active-ingredient family
Ammonium chloride
Ammonium chloride: 1 brand, 4 generics; first approved Jun 13, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
4
Listed patents
0
Presentations
5
Brand (NDA) products
Originator applications
- MCGAWNDA 006580—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 900MG/100ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (4)
Abbreviated applications
- HOSPIRAANDA 0883661984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MEQ/ML INJECTABLE INJECTION Rx — - AMMONIUM CHLORIDEABBOTTANDA 083130—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MEQ/ML INJECTABLE INJECTION Discontinued — - AMMONIUM CHLORIDEGD SEARLE LLCANDA 086205—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MEQ/ML INJECTABLE INJECTION Discontinued — - B BRAUNANDA 085734—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MEQ/100ML INJECTABLE INJECTION Discontinued —
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
42 yr 9 mo ago
Most recent approval
42 yr 9 mo ago
All 5 applications were approved in 1984.
Brand (NDA) 120%
Generic (ANDA) 480%
Ammonium chloride: 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.
