FDA Orange Book · active-ingredient family
Cosyntropin
Cosyntropin: 2 brands, 2 generics; first approved Feb 21, 2008; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
2
Listed patents
0
Presentations
4
Brand (NDA) products
Originator applications
- AMPHASTAR PHARMS INCNDA 016750—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/VIAL INJECTABLE INJECTION Rx AP - COSYNTROPINSANDOZNDA 0220282008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/ML (0.25MG/ML) SOLUTION INTRAVENOUS Discontinued —
Generic (ANDA) products (2)
Abbreviated applications
- COSYNTROPINSANDOZANDA 2021472012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/VIAL INJECTABLE INJECTION Rx AP - COSYNTROPINPHARMOBEDIENTANDA 0905742009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/VIAL 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
18 yr 9 mo ago
Most recent approval
14 yr 4 mo ago
Approvals span 2008–2012 across 4 FDA applications.
Brand (NDA) 250%
Generic (ANDA) 250%
Cosyntropin: 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.
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- 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.
