Assyro AI

FDA Orange Book · active-ingredient family

Prednisolone

Prednisolone is approved as 3 brand and 51 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:METI-DERM · NDA 010209

3

Brand (NDA)

51

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · cream, solution, syrup, tablet

ProductApplicantApplicationTEApproved
METI-DERMSCHERINGNDA 010209—Approved Prior to Jan 1, 1982
DELTA-CORTEFPHARMACIA AND UPJOHNNDA 009987—Approved Prior to Jan 1, 1982
STERANEPFIZERNDA 009996—Approved Prior to Jan 1, 1982

Generic (ANDA) products (51)

ProductApplicantApplicationTEApproved
PREDNISOLONETP ANDA HOLDINGSANDA 219509AAJun 23, 2025
PREDNISOLONEZHEJIANG XIANJUANDA 218083ABMay 02, 2024
PREDNISOLONEAUROBINDO PHARMA LTDANDA 215673ABMar 17, 2023
PREDNISOLONELANNETT CO INCANDA 040775AASep 21, 2007
PREDNISOLONEPHARM ASSOCANDA 040571AAAug 25, 2005
PREDNISOLONEPHARM ASSOCANDA 040570—Aug 25, 2005
PREDNISOLONEPHARMOBEDIENT CNSLTGANDA 040313—Sep 10, 2003
PREDNISOLONEPHARM ASSOCANDA 040399—Mar 05, 2003
PREDNISOLONEHIKMAANDA 040401—Feb 27, 2003
PREDNISOLONENESHER PHARMSANDA 040364—Apr 10, 2002
PREDNISOLONENESHER PHARMSANDA 040423—Oct 22, 2001
PREDNISOLONETEVA PHARMSANDA 040322—Jan 19, 2000
PREDNISOLONEIVAX SUB TEVA PHARMSANDA 040287—May 28, 1999
PREDNISOLONECHARTWELL RXANDA 040323AAMay 13, 1999
PREDNISOLONEWE PHARMSANDA 040192—May 28, 1998
PRELONEMUROANDA 089654—Jan 17, 1989
PRELONETEVAANDA 089081AAFeb 04, 1986
PREDNISOLONESUPERPHARMANDA 088892—Feb 26, 1985
PREDNISOLONEUDLANDA 087987—Jan 18, 1983
CORTALONE×3HALSEYANDA 080304—Approved Prior to Jan 1, 1982
FERNISOLONE-PFERNDALE LABSANDA 083941—Approved Prior to Jan 1, 1982
PREDNISOLONEBARRANDA 084426—Approved Prior to Jan 1, 1982
PREDNISOLONEBUNDYANDA 083675—Approved Prior to Jan 1, 1982
PREDNISOLONECHARTWELL MOLECULARANDA 080531BXApproved Prior to Jan 1, 1982
PREDNISOLONECHARTWELL RXANDA 084542—Approved Prior to Jan 1, 1982
PREDNISOLONEELKINS SINNANDA 080625—Approved Prior to Jan 1, 1982
PREDNISOLONE×3EVERYLIFEANDA 084439—Approved Prior to Jan 1, 1982
PREDNISOLONE×2FERRANTEANDA 080562—Approved Prior to Jan 1, 1982
PREDNISOLONEFOSUN PHARMAANDA 080339—Approved Prior to Jan 1, 1982
PREDNISOLONERLDHEATHERANDA 080326—Approved Prior to Jan 1, 1982
PREDNISOLONEIMPAX LABSANDA 080780—Approved Prior to Jan 1, 1982
PREDNISOLONEINWOOD LABSANDA 080748—Approved Prior to Jan 1, 1982
PREDNISOLONEIVAX SUB TEVA PHARMSANDA 080378—Approved Prior to Jan 1, 1982
PREDNISOLONEMARSHALL PHARMAANDA 080307—Approved Prior to Jan 1, 1982
PREDNISOLONE×2PANRAYANDA 080351—Approved Prior to Jan 1, 1982
PREDNISOLONEPHOENIX LABS NYANDA 080322—Approved Prior to Jan 1, 1982
PREDNISOLONEPUREPAC PHARMANDA 080325—Approved Prior to Jan 1, 1982
PREDNISOLONEPVT FORMANDA 080211—Approved Prior to Jan 1, 1982
PREDNISOLONERISINGANDA 084773—Approved Prior to Jan 1, 1982
PREDNISOLONEROXANEANDA 080327—Approved Prior to Jan 1, 1982
PREDNISOLONE×3SPERTIANDA 080358—Approved Prior to Jan 1, 1982
PREDNISOLONETABLICAPSANDA 085170—Approved Prior to Jan 1, 1982
PREDNISOLONETEVAANDA 080398—Approved Prior to Jan 1, 1982
PREDNISOLONEVALEANT PHARM INTLANDA 080236—Approved Prior to Jan 1, 1982
PREDNISOLONEVITARINEANDA 080534—Approved Prior to Jan 1, 1982
PREDNISOLONERLDWATSON LABSANDA 080354ABApproved Prior to Jan 1, 1982
PREDNISOLONEWATSON LABSANDA 085085—Approved Prior to Jan 1, 1982
PREDNISOLONEWATSON LABSANDA 085415—Approved Prior to Jan 1, 1982
PREDNISOLONEWATSON LABSANDA 085416—Approved Prior to Jan 1, 1982
PREDNISOLONEWEST WARDANDA 080324—Approved Prior to Jan 1, 1982
PREDNISOLONEWHITEWORTH TOWN PLSNANDA 080342—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.

Prednisolone — 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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