FDA Orange Book · active-ingredient family
Aztreonam
Aztreonam: 3 brands, 4 generics; first approved Dec 31, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
4
Listed patents
0
Presentations
16
Brand (NDA) products
Originator applications
- GILEADNDA 0508142010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG/VIAL FOR SOLUTION INHALATION Rx — - BRISTOL MYERS SQUIBBNDA 05063219893 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — 20MG/ML INJECTABLE INJECTION Discontinued — 10MG/ML INJECTABLE INJECTION Discontinued — - LABS DELBERTNDA 05058019863 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Discontinued — 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP
Generic (ANDA) products (4)
Abbreviated applications
- AZTREONAMHIKMAANDA 20706920262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/VIAL INJECTABLE INJECTION Discontinued — 2GM/VIAL INJECTABLE INJECTION Discontinued — - AZTREONAMHOSPIRAANDA 20651720212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP - AZTREONAMHIKMAANDA 06528620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/VIAL INJECTABLE INJECTION Discontinued — 2GM/VIAL INJECTABLE INJECTION Discontinued — - AZTREONAMFRESENIUS KABI USAANDA 06543920103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx — 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP
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
40 yr 3 mo ago
Most recent approval
7 mo ago
Approvals span 1986–2026 across 7 FDA applications.
Brand (NDA) 343%
Generic (ANDA) 457%
Aztreonam: 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.
