Assyro AI

FDA Orange Book · active-ingredient family

Cortisone acetate

Cortisone acetate is approved as 5 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CORTONE · NDA 007750

5

Brand (NDA)

15

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, tablet

ProductApplicantApplicationTEApproved
CORTONERLDMERCKNDA 007750—Approved Prior to Jan 1, 1982
CORTISONE ACETATE×4PHARMACIA AND UPJOHNNDA 008126—Approved Prior to Jan 1, 1982
CORTONE×2MERCKNDA 007110—Approved Prior to Jan 1, 1982
CORTISONE ACETATEIMPAX LABSNDA 009458—Approved Prior to Jan 1, 1982
CORTISONE ACETATE×2PANRAYNDA 008284—Approved Prior to Jan 1, 1982

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
CORTISONE ACETATE×2WATSON LABSANDA 083147—Approved Prior to Jan 1, 1982
CORTISONE ACETATE×2WATSON LABSANDA 085677—Approved Prior to Jan 1, 1982
CORTISONE ACETATEBARRANDA 083471—Approved Prior to Jan 1, 1982
CORTISONE ACETATECHARTWELL MOLECULARANDA 080694—Approved Prior to Jan 1, 1982
CORTISONE ACETATEELKINS SINNANDA 080836—Approved Prior to Jan 1, 1982
CORTISONE ACETATEEVERYLIFEANDA 084246—Approved Prior to Jan 1, 1982
CORTISONE ACETATEHEATHERANDA 085736—Approved Prior to Jan 1, 1982
CORTISONE ACETATEHIKMA INTL PHARMSANDA 080776—Approved Prior to Jan 1, 1982
CORTISONE ACETATEINWOOD LABSANDA 080731—Approved Prior to Jan 1, 1982
CORTISONE ACETATEIVAX SUB TEVA PHARMSANDA 080630—Approved Prior to Jan 1, 1982
CORTISONE ACETATEIVAX SUB TEVA PHARMSANDA 083536—Approved Prior to Jan 1, 1982
CORTISONE ACETATEPUREPAC PHARMANDA 080493—Approved Prior to Jan 1, 1982
CORTISONE ACETATEVITARINEANDA 080333—Approved Prior to Jan 1, 1982
CORTISONE ACETATEWATSON LABSANDA 085884—Approved Prior to Jan 1, 1982
CORTISONE ACETATEWHITEWORTH TOWN PLSNANDA 080341—Approved Prior to Jan 1, 1982

Listed patents

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.

Agent CTA Background

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