FDA Orange Book · active-ingredient family
Prednisone
Prednisone: 5 brands, 118 generics; first approved Jan 15, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 118 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
5
Generics (ANDA)
118
Listed patents
2
Next patent expiry
Aug 03, 2027
in 1 yr
Brand (NDA) products
Originator applications
- RAYOSRLDHORIZONNDA 20202020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET, DELAYED RELEASE ORAL Discontinued — 2MG TABLET, DELAYED RELEASE ORAL Discontinued — 5MG TABLET, DELAYED RELEASE ORAL Discontinued — - DELTASONERLDPHARMACIA AND UPJOHNNDA 009986—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - METICORTENRLDSCHERINGNDA 009766—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - PARKE DAVISNDA 010962—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEROXANENDA 017109—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued —
Generic (ANDA) products (118)
Abbreviated applications
- PREDNISONERSDR REDDYSANDA 2180352026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, DELAYED RELEASE ORAL Rx — - PREDNISONEDR REDDYSANDA 21947720252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET, DELAYED RELEASE ORAL Rx — 2MG TABLET, DELAYED RELEASE ORAL Rx — - PREDNISONEPOINTVIEW HLDINGSANDA 21262920233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - PREDNISONEJUBILANT CADISTAANDA 04036220235 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - PREDNISONEAUROBINDO PHARMA LTDANDA 21567220225 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - PREDNISONEAUROBINDO PHARMA LTDANDA 2156712021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - PREDNISONENOVITIUM PHARMAANDA 2152462021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - PREDNISONESTRIDES PHARMAANDA 20841220205 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB - PREDNISONESTRIDES PHARMAANDA 2107852020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - PREDNISONEAMNEALANDA 21338620202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - PREDNISONEAMNEALANDA 21338520202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB - PREDNISONENOVITIUM PHARMAANDA 21157520195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - PREDNISONEGENEYORK PHARMSANDA 2114962018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - PREDNISONEGENEYORK PHARMSANDA 21052520185 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — - PREDNISONEACTAVIS LABS FL INCANDA 20486720173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET, DELAYED RELEASE ORAL Discontinued — 2MG TABLET, DELAYED RELEASE ORAL Discontinued — 5MG TABLET, DELAYED RELEASE ORAL Discontinued — - PREDNISONEHIKMA PHARMSANDA 0408902010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - PREDNISONEJUBILANT CADISTAANDA 0406112005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - PREDNISONEPH HEALTHANDA 0405842004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - PREDNISONEPH HEALTHANDA 0405812004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB - PREDNISONEHIKMA PHARMSANDA 0405382004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - PREDNISONEPH HEALTHANDA 0403922003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - PREDNISONEPH HEALTHANDA 04025620022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - PREDNISONERISINGANDA 0899831989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONERISINGANDA 0899841989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - PREDNISONEXTTRIUM LABS INCANDA 0897261988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — - PREDNISONEAMNEAL PHARMS NYANDA 0895971987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEAMNEAL PHARMS NYANDA 0895981987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONEAMNEAL PHARMS NYANDA 0895991987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEAM THERAPANDA 0893871986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEAM THERAPANDA 0893881986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONEAM THERAPANDA 0893891986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEWHITEWORTH TOWN PLSNANDA 0890281986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONESUN PHARM INDUSTRIESANDA 08924719853 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - HIKMAANDA 0888101985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML SOLUTION ORAL Rx — - PREDNISONERLDRSHIKMAANDA 0887031984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx — - PREDNISONESUPERPHARMANDA 0888651984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONESUPERPHARMANDA 0888661984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONESUPERPHARMANDA 0888671984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEHIKMA PHARMSANDA 0884651984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - PREDNISONEDURAMED PHARMS BARRANDA 0883941983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEDURAMED PHARMS BARRANDA 0883951983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONEDURAMED PHARMS BARRANDA 0883961983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEUDLANDA 0879841983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEUDLANDA 0879851983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONEUDLANDA 0879861983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - MUROANDA 0876111982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SYRUP ORAL Discontinued — - PREDNISONEWATSON LABSANDA 0877731982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONEWATSON LABSANDA 0877721982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - PREDNISONERLDROXANEANDA 0878331982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - PREDNISONERLDRSHIKMAANDA 08035219826 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - PREDNISONEVANGARDANDA 0876821982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEVANGARDANDA 0877011982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - HALSEYANDA 087480—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - BAYER PHARMSANDA 080293—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - FERNDALE LABSANDA 083364—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - SOLVAYANDA 083009—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - SOLVAYANDA 085999—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - SCHWARZ PHARMAANDA 084655—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEAIPING PHARM INCANDA 080336—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEBUNDYANDA 083676—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONECHARTWELL MOLECULARANDA 080514—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONECHARTWELL MOLECULARANDA 084275—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx BX - PREDNISONECHARTWELL RXANDA 083059—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONECONTRACT PHARMACALANDA 080209—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEELKINS SINNANDA 080491—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEELKINS SINNANDA 085811—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEEVERYLIFEANDA 084440—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — - PREDNISONEFERRANTEANDA 080563—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — - PREDNISONEHALSEYANDA 080300—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEHEATHERANDA 080320—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEHEATHERANDA 084341—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONEHEATHERANDA 084417—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEHEATHERANDA 085543—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEHEATHERANDA 086946—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - PREDNISONEIMPAX LABSANDA 080782—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEINWOOD LABSANDA 080328—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - PREDNISONEINWOOD LABSANDA 080306—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - PREDNISONEINWOOD LABSANDA 080279—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEIVAX SUB TEVA PHARMSANDA 080283—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEIVAX SUB TEVA PHARMSANDA 084133—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONEIVAX SUB TEVA PHARMSANDA 084134—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEKV PHARMANDA 084236—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONELEDERLEANDA 086968—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEMARSHALL PHARMAANDA 080301—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEMUTUAL PHARMANDA 080701—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEMUTUAL PHARMANDA 086595—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONEMUTUAL PHARMANDA 084634—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEMYLANANDA 083677—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - PREDNISONENYLOSANDA 085115—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEPANRAYANDA 080350—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — - PREDNISONEPHARMAVITEANDA 084662—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEPHOENIX LABS NYANDA 080321—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEPHOENIX LABS NYANDA 083807—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEPUREPAC PHARMANDA 080353—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEPUREPAC PHARMANDA 086062—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PREDNISONEPUREPAC PHARMANDA 086061—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEPVT FORMANDA 085151—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEREXALLANDA 080232—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONERISINGANDA 084774—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONERISINGANDA 085813—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONESCHERER LABSANDA 080371—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONESPERTIANDA 080359—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — - PREDNISONESUN PHARM INDUSTRIESANDA 086596—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - PREDNISONETEVAANDA 080397—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEUPSHER SMITHANDA 087471—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEUPSHER SMITHANDA 087470—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEVALEANT PHARM INTLANDA 080237—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEVITARINEANDA 080334—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEVITARINEANDA 080506—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEWATSON LABSANDA 080356—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - PREDNISONEWATSON LABSANDA 085084—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - PREDNISONEWATSON LABSANDA 085162—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - PREDNISONEWATSON LABSANDA 085161—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - PREDNISONEWATSON LABSANDA 086813—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PREDNISONEWATSON LABSANDA 086867—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - PREDNISONEWHITEWORTH TOWN PLSNANDA 084913—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - PREDNISONEWHITEWORTH TOWN PLSNANDA 080343—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - LEDERLEANDA 080223—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9504699 | in 1 yr | U-1362 | |
| 8168218 | in 1 yr 5 mo | ProductU-1269 |
Approval history
FDA approval span
First approval
45 yr 2 mo ago
Most recent approval
1 mo ago
Approvals span 1982–2026 across 123 FDA applications.
Brand (NDA) 54%
Generic (ANDA) 11896%
Prednisone: 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.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
