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FDA Orange Book · active-ingredient family

Prednisolone sodium phosphate

Prednisolone sodium phosphate is approved as 4 brand and 35 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ORAPRED ODT · NDA 021959

4

Brand (NDA)

35

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, ointment, solution, solution/drops, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
ORAPRED ODTRLD×3ADVANZ PHARMANDA 021959—Jun 01, 2006
PEDIAPREDRLDPAI HOLDINGSNDA 019157AAMay 28, 1986
HYDELTRASOLMERCKNDA 011583—Approved Prior to Jan 1, 1982
HYDELTRASOLMERCKNDA 011028—Approved Prior to Jan 1, 1982

Generic (ANDA) products (35)

ProductApplicantApplicationTEApproved
PREDNISOLONE SODIUM PHOSPHATEAMNEALANDA 216715AAOct 25, 2022
PREDNISOLONE SODIUM PHOSPHATEPHARM ASSOCANDA 204962—Mar 11, 2020
PREDNISOLONE SODIUM PHOSPHATE×4EDENBRIDGE PHARMSANDA 203559AADec 20, 2016
PREDNISOLONE SODIUM PHOSPHATE×3RISINGANDA 202179—Apr 10, 2013
PREDNISOLONE SODIUM PHOSPHATEMISSION PHARMAANDA 091396AASep 13, 2010
PREDNISOLONE SODIUM PHOSPHATEPH HEALTHANDA 079010—May 26, 2009
PREDNISOLONE SODIUM PHOSPHATEAMNEAL PHARMSANDA 078345—Mar 10, 2009
PREDNISOLONE SODIUM PHOSPHATEPHARM ASSOCANDA 078988AAJun 09, 2008
PREDNISOLONE SODIUM PHOSPHATEPHARM ASSOCANDA 078465AAMar 07, 2008
PREDNISOLONE SODIUM PHOSPHATEVINTAGE PHARMSANDA 078416—Oct 31, 2007
PREDNISOLONE SODIUM PHOSPHATENESHER PHARMSANDA 076982—May 24, 2005
PREDNISOLONE SODIUM PHOSPHATENESHER PHARMSANDA 076988—May 24, 2005
PREDNISOLONE SODIUM PHOSPHATEPHARM ASSOCANDA 076913AAApr 25, 2005
PREDNISOLONE SODIUM PHOSPHATEPHARMOBEDIENTANDA 076895—Oct 04, 2004
PREDNISOLONE SODIUM PHOSPHATECHARTWELL RXANDA 075988AAMay 25, 2004
PREDNISOLONE SODIUM PHOSPHATEHIKMAANDA 075183—Mar 26, 2003
PREDNISOLONE SODIUM PHOSPHATEPHARM ASSOCANDA 076123—Dec 23, 2002
PREDNISOLONE SODIUM PHOSPHATEWE PHARMSANDA 075181—Dec 23, 2002
PREDNISOLONE SODIUM PHOSPHATEBAUSCHANDA 075250—Jul 12, 2002
PREDNISOLONE SODIUM PHOSPHATEPHARMOBEDIENT CNSLTGANDA 075099—Jun 28, 2002
ORAPREDCONCORDIA PHARMS INCANDA 075117—Dec 14, 2000
PREDNISOLONE SODIUM PHOSPHATEBAUSCH AND LOMBANDA 040065—Jul 29, 1994
PREDNISOLONE SODIUM PHOSPHATEBAUSCH AND LOMB INCANDA 040070—Jul 29, 1994
PREDNISOLONE SODIUM PHOSPHATEALCON PHARMS LTDANDA 081043—Oct 24, 1991
PREDNISOLONE SODIUM PHOSPHATEALCON PHARMS LTDANDA 081044—Oct 24, 1991
PREDAIRPHARMAFAIRANDA 088415—Feb 29, 1984
PREDAIR FORTEPHARMAFAIRANDA 088165—Mar 28, 1983
PREDNISOLONE SODIUM PHOSPHATEWATSON LABSANDA 080517—Approved Prior to Jan 1, 1982
INFLAMASE FORTERLD×2NOVARTISANDA 080751—Approved Prior to Jan 1, 1982
METRETONSCHERINGANDA 083834—Approved Prior to Jan 1, 1982
PREDNISOLONE SODIUM PHOSPHATE×2EPIC PHARMA LLCANDA 083358—Approved Prior to Jan 1, 1982
PREDNISOLONE SODIUM PHOSPHATESOLA BARNES HINDANDA 084171—Approved Prior to Jan 1, 1982
PREDNISOLONE SODIUM PHOSPHATESOLA BARNES HINDANDA 084168—Approved Prior to Jan 1, 1982
PREDNISOLONE SODIUM PHOSPHATESOLA BARNES HINDANDA 084169—Approved Prior to Jan 1, 1982
PREDNISOLONE SODIUM PHOSPHATESOLA BARNES HINDANDA 084172—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 sodium phosphate — 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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