Deflazacort
Deflazacort: 2 brands, 11 generics; first approved Feb 09, 2017; generic available.
Generic available: 11 ANDA applications approved.
Brand (NDA) products
- PTC THERAPNDA 2086852017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 22.75MG/ML SUSPENSION ORAL Rx AB - EMFLAZARLDPTC THERAPNDA 20868420174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Rx AB 18MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 36MG TABLET ORAL Rx AB
Generic (ANDA) products (11)
- DEFLAZACORTBIOCON PHARMAANDA 2207092026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 22.75MG/ML SUSPENSION ORAL Rx AB - DEFLAZACORTSUN PHARM INDS INCANDA 2199302026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 22.75MG/ML SUSPENSION ORAL Rx AB - DEFLAZACORTAMNEALANDA 21717320254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Rx AB 18MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 36MG TABLET ORAL Rx AB - DEFLAZACORTZYDUS LIFESCIENCESANDA 2200422025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 22.75MG/ML SUSPENSION ORAL Rx AB - DEFLAZACORTUPSHER SMITH LABSANDA 2169922025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 22.75MG/ML SUSPENSION ORAL Rx AB - AUCTAANDA 2194172025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 22.75MG/ML SUSPENSION ORAL Rx AB - ZYDUS LIFESCIENCESANDA 21925420254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Rx AB 18MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 36MG TABLET ORAL Rx AB - DEFLAZACORTSUN PHARMANDA 21774120254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Rx AB 18MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 36MG TABLET ORAL Rx AB - DEFLAZACORTUPSHER SMITH LABSANDA 21672020244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Rx AB 18MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 36MG TABLET ORAL Rx AB - DEFLAZACORTTRIS PHARMA INCANDA 2178132024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 22.75MG/ML SUSPENSION ORAL Rx AB - DEFLAZACORTAUROBINDO PHARMA LTDANDA 21712320244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Rx AB 18MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 36MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Marketing exclusivity
- ODE-252Orphan-drug exclusivity (7 years)
5 mo ago
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.
Approval history
Approvals span 2017–2026 across 13 FDA applications.
Deflazacort: 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.
Assyro Intelligence
Ask anything about Deflazacort
Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.
Evaluating for a team? Book a demo