FDA.reportPublic FDA data

Application 022272

Type
NDA
Sponsor
PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCONTINOXYCODONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MGYesNo
002OXYCONTINOXYCODONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL15MGYesNo
003OXYCONTINOXYCODONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL20MGYesNo
004OXYCONTINOXYCODONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL30MGYesNo
005OXYCONTINOXYCODONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL40MGYesYes
006OXYCONTINOXYCODONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL60MGYesNo
007OXYCONTINOXYCODONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL80MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022272-001OXYCONTINOXYCODONE HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05
N022272-002OXYCONTINOXYCODONE HYDROCHLORIDE15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05
N022272-003OXYCONTINOXYCODONE HYDROCHLORIDE20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05
N022272-004OXYCONTINOXYCODONE HYDROCHLORIDE30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05
N022272-005OXYCONTINOXYCODONE HYDROCHLORIDE40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-05
N022272-006OXYCONTINOXYCODONE HYDROCHLORIDE60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05
N022272-007OXYCONTINOXYCODONE HYDROCHLORIDE80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05

Orange Book patents#

Current patent rows page 1 of 2 · 102 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022272-001113049082027-08-24Drug product2022-04-21
N022272-001113049092027-08-24U-15562022-04-21
N022272-001119640562027-08-24Drug product2024-04-25
N022272-001122460942027-08-24Drug product2025-03-14
N022272-001122801522027-08-24Drug product2025-05-22
N022272-00188087412027-08-24U-15562014-08-19
N022272-00188949882027-08-24Drug product2014-11-25
N022272-00194923892027-08-24Drug product2016-11-16
N022272-00194923912027-08-24U-15562016-11-16
N022272-00194923922027-08-24Drug product2016-11-16
N022272-00194923932027-08-24U-15562016-11-16
N022272-00197639332027-08-24Drug product2017-09-19
N022272-00197704162027-08-24Drug product2017-09-27
N022272-00197758082027-08-24Drug product2017-10-04
N022272-00188949872030-03-29Drug product2014-11-25
N022272-002113049082027-08-24Drug product2022-04-21
N022272-002113049092027-08-24U-15562022-04-21
N022272-002119640562027-08-24Drug product2024-04-25
N022272-002122460942027-08-24Drug product2025-03-14
N022272-002122801522027-08-24Drug product2025-05-22
N022272-00288087412027-08-24U-15562014-08-19
N022272-00288949882027-08-24Drug product2014-11-25
N022272-00294923892027-08-24Drug product2016-11-16
N022272-00294923912027-08-24U-15562016-11-16
N022272-00294923922027-08-24Drug product2016-11-16
N022272-00294923932027-08-24U-15562016-11-16
N022272-00297639332027-08-24Drug product2017-09-19
N022272-00297704162027-08-24Drug product2017-09-27
N022272-00297758082027-08-24Drug product2017-10-04
N022272-00288949872030-03-29Drug product2014-11-25
N022272-003113049082027-08-24Drug product2022-04-21
N022272-003113049092027-08-24U-15562022-04-21
N022272-003119640562027-08-24Drug product2024-04-25
N022272-003122460942027-08-24Drug product2025-03-14
N022272-003122801522027-08-24Drug product2025-05-22
N022272-00388087412027-08-24U-15562014-08-19
N022272-00388949882027-08-24Drug product2014-11-25
N022272-00394923892027-08-24Drug product2016-11-16
N022272-00394923912027-08-24U-15562016-11-16
N022272-00394923922027-08-24Drug product2016-11-16
N022272-00394923932027-08-24U-15562016-11-16
N022272-00397639332027-08-24Drug product2017-09-19
N022272-00397704162027-08-24Drug product2017-09-27
N022272-00397758082027-08-24Drug product2017-10-04
N022272-00388949872030-03-29Drug product2014-11-25
N022272-004113049082027-08-24Drug product2022-04-21
N022272-004113049092027-08-24U-15562022-04-21
N022272-004119640562027-08-24Drug product2024-04-25
N022272-004122460942027-08-24Drug product2025-03-14
N022272-004122801522027-08-24Drug product2025-05-22
N022272-00488087412027-08-24U-15562014-08-19
N022272-00488949882027-08-24Drug product2014-11-25
N022272-00494923892027-08-24Drug product2016-11-16
N022272-00494923912027-08-24U-15562016-11-16
N022272-00494923922027-08-24Drug product2016-11-16
N022272-00494923932027-08-24U-15562016-11-16
N022272-00497639332027-08-24Drug product2017-09-19
N022272-00497704162027-08-24Drug product2017-09-27
N022272-00497758082027-08-24Drug product2017-10-04
N022272-00488949872030-03-29Drug product2014-11-25
N022272-005113049082027-08-24Drug product2022-04-21
N022272-005113049092027-08-24U-15562022-04-21
N022272-005119640562027-08-24Drug product2024-04-25
N022272-005122460942027-08-24Drug product2025-03-14
N022272-005122801522027-08-24Drug product2025-05-22
N022272-00588087412027-08-24U-15562014-08-19
N022272-00588949882027-08-24Drug product2014-11-25
N022272-00594923892027-08-24Drug product2016-11-16
N022272-00594923912027-08-24U-15562016-11-16
N022272-00594923922027-08-24Drug product2016-11-16
N022272-00594923932027-08-24U-15562016-11-16
N022272-00597639332027-08-24Drug product2017-09-19
N022272-00597704162027-08-24Drug product2017-09-27
N022272-00597758082027-08-24Drug product2017-10-04
N022272-006113049082027-08-24Drug product2022-04-21
N022272-006113049092027-08-24U-15562022-04-21
N022272-006119640562027-08-24Drug product2024-04-25
N022272-006122460942027-08-24Drug product2025-03-14
N022272-006122801522027-08-24Drug product2025-05-22
N022272-00688087412027-08-24U-15562014-08-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-0503ed91905a0d…

Observed Orange Book patent history#

Patent history page 1 of 134 · 5,340 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022272-001113049082027-08-24Drug product2022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-001113049092027-08-24U-15562022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-001119640562027-08-24Drug product2024-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-001122460942027-08-24Drug product2025-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-001122801522027-08-24Drug product2025-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00188087412027-08-24U-15562014-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00188949882027-08-24Drug product2014-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00194923892027-08-24Drug product2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00194923912027-08-24U-15562016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00194923922027-08-24Drug product2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00194923932027-08-24U-15562016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00197639332027-08-24Drug product2017-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00197704162027-08-24Drug product2017-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00197758082027-08-24Drug product2017-10-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00188949872030-03-29Drug product2014-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002113049082027-08-24Drug product2022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002113049092027-08-24U-15562022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002119640562027-08-24Drug product2024-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002122460942027-08-24Drug product2025-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002122801522027-08-24Drug product2025-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00288087412027-08-24U-15562014-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00288949882027-08-24Drug product2014-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00294923892027-08-24Drug product2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00294923912027-08-24U-15562016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00294923922027-08-24Drug product2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00294923932027-08-24U-15562016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00297639332027-08-24Drug product2017-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00297704162027-08-24Drug product2017-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00297758082027-08-24Drug product2017-10-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00288949872030-03-29Drug product2014-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003113049082027-08-24Drug product2022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003113049092027-08-24U-15562022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003119640562027-08-24Drug product2024-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003122460942027-08-24Drug product2025-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003122801522027-08-24Drug product2025-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00388087412027-08-24U-15562014-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00388949882027-08-24Drug product2014-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00394923892027-08-24Drug product2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00394923912027-08-24U-15562016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00394923922027-08-24Drug product2016-11-16011fe1cb6892…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxyContinOXYCODONE HYDROCHLORIDEKnoa Pharma LLCbfdfe235-d717-4855-a3c8-a13d26dadede2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022272
application number: NDA022272
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f2026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022272
application number: NDA022272
ndc (product): 0115-1557
ndc (product): 0115-1559
ndc (product): 0115-1561
ndc (product): 0115-1556
ndc (product): 0115-1558
ndc (product): 0115-1560
ndc (product): 0115-1562

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 143 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5731Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5731Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5731Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5731Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5731Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5731Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5731Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5731Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5732Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5732Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5732Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5732Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5732Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5732Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5732Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5732Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5733Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5733Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5733Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5733Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5733Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5733Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5733Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5733Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5734Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5734Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5734Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5734Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5734Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5734Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5734Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-5734Oxycodone HydrochlorideOxycodone HydrochlorideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0115-1556OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1556OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1556OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1557OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1557OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1557OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1558OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1558OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1558OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1559OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1559OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1559OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1560OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1560OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1560OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1561OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1561OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1561OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1562OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1562OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1562OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0591-2693Oxycodone Hydrochlorideoxycodone hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2693Oxycodone Hydrochlorideoxycodone hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2693Oxycodone Hydrochlorideoxycodone hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2693Oxycodone Hydrochlorideoxycodone hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2708Oxycodone Hydrochlorideoxycodone hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2708Oxycodone Hydrochlorideoxycodone hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2708Oxycodone Hydrochlorideoxycodone hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2708Oxycodone Hydrochlorideoxycodone hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0781-5703oxycodone hydrochlorideoxycodone hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5726oxycodone hydrochlorideoxycodone hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5767oxycodone hydrochlorideoxycodone hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5785oxycodone hydrochlorideoxycodone hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
10702-801OXYCODONE HClOXYCODONE HClKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-801OXYCODONE HClOXYCODONE HClKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-803OXYCODONE HClOXYCODONE HClKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-803OXYCODONE HClOXYCODONE HClKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-805OXYCODONE HClOXYCODONE HClKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-805OXYCODONE HClOXYCODONE HClKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
21695-941OxyContinoxycodone hydrochlorideRebel Distributors CorpNDACurrent
21695-951OxyContinoxycodone hydrochlorideRebel Distributors CorpNDACurrent
31722-109Oxycodone HydrochlorideOxycodone HydrochlorideCamber Pharmaceuticals, Inc.NDACurrent
31722-110Oxycodone HydrochlorideOxycodone HydrochlorideCamber Pharmaceuticals, Inc.NDACurrent
31722-111Oxycodone HydrochlorideOxycodone HydrochlorideCamber Pharmaceuticals, Inc.NDACurrent
42254-159OxyContinoxycodone hydrochlorideRebel Distributors CorpNDACurrent
49884-136oxycodone hydrochlorideoxycodone hydrochloridePar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
49884-137oxycodone hydrochlorideoxycodone hydrochloridePar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
49884-138oxycodone hydrochlorideoxycodone hydrochloridePar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84662SUPPL 2026-01-06
84610SUPPL 2025-12-31
80074SUPPL 2024-11-04
77031SUPPL 2023-12-19
76930SUPPL 2023-12-18
76929SUPPL 2023-12-18
69175SUPPL2021-10-29
69174SUPPL2021-10-29
69151SUPPL2021-10-29
66607SUPPL2021-03-08
66606SUPPL2021-03-08
66558SUPPL2021-03-05
60857SUPPL2019-11-15
60848SUPPL2019-11-15
60442SUPPL2019-10-09
60381SUPPL2019-10-09
60380SUPPL2019-10-08
55775SUPPL2018-10-01
55774SUPPL2018-10-01
55758SUPPL2018-10-01
55700SUPPL2018-10-01
55699SUPPL2018-10-01
55630SUPPL2018-09-27
48567SUPPL2017-05-30
46341SUPPL2016-12-21
46299SUPPL2016-12-20
45466SUPPL2016-10-04
24023ORIG2015-11-04
42477SUPPL2015-09-29
29504SUPPL2015-08-13
17180SUPPL2015-08-13
7153SUPPL2015-07-06
29502SUPPL2014-10-30
17179SUPPL2014-10-30
29503SUPPL2014-08-20
7152SUPPL2014-04-17
17178SUPPL2014-04-16
42476SUPPL2013-04-26
38481SUPPL2013-04-16
29501SUPPL2013-04-16
29500SUPPL2013-04-16
44179ORIG2013-02-15
38482SUPPL2013-01-15
7151SUPPL2013-01-14
38480SUPPL2012-07-13
38479SUPPL2012-07-12
7150SUPPL2012-07-11
7149SUPPL2012-07-11
17177SUPPL2011-10-12
7148SUPPL2011-10-11
44723ORIG2011-02-17
38478SUPPL2010-11-26
7147SUPPL2010-11-22
21975ORIG2010-09-29
44493ORIG2010-08-06
38477SUPPL2010-07-01
7146SUPPL2010-07-01
7145ORIG2010-04-09
17176ORIG2010-04-06
51536ORIG1900-01-01
51535ORIG1900-01-01
51534ORIG1900-01-01