FDA Orange Book · active-ingredient family
Cortisone acetate
Cortisone acetate: 5 brands, 15 generics; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Brands (NDA)
5
Generics (ANDA)
15
Listed patents
0
Presentations
27
Brand (NDA) products
Originator applications
- CORTONERLDMERCKNDA 007750—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEPHARMACIA AND UPJOHNNDA 008126—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 25MG/ML INJECTABLE INJECTION Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - MERCKNDA 007110—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — 50MG/ML INJECTABLE INJECTION Discontinued — - CORTISONE ACETATEIMPAX LABSNDA 009458—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEPANRAYNDA 008284—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued —
Generic (ANDA) products (15)
Abbreviated applications
- CORTISONE ACETATEWATSON LABSANDA 083147—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — 50MG/ML INJECTABLE INJECTION Discontinued — - CORTISONE ACETATEWATSON LABSANDA 085677—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — 50MG/ML INJECTABLE INJECTION Discontinued — - CORTISONE ACETATEBARRANDA 083471—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATECHARTWELL MOLECULARANDA 080694—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEELKINS SINNANDA 080836—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEEVERYLIFEANDA 084246—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEHEATHERANDA 085736—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEHIKMA INTL PHARMSANDA 080776—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEINWOOD LABSANDA 080731—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEIVAX SUB TEVA PHARMSANDA 080630—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEIVAX SUB TEVA PHARMSANDA 083536—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEPUREPAC PHARMANDA 080493—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEVITARINEANDA 080333—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEWATSON LABSANDA 085884—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CORTISONE ACETATEWHITEWORTH TOWN PLSNANDA 080341—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL 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.
Cortisone acetate: 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.
