FDA.reportPublic FDA data

Application 091633

Type
ANDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL2.5MG;200MGNoNo
002HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL5MG;200MGNoNo
003HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL7.5MG;200MGNoNo
004HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL10MG;200MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091633-001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-28
A091633-002HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN5MG;200MGTABLET / ORAL2013-05-28
A091633-003HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-28
A091633-004HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN10MG;200MGTABLET / ORAL2013-05-28

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-2887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-2887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-2887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-285aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-285aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-285aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-288869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-288869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-288869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-28c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-28c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-28c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-283f01610625f2…
2019-12-14 00:12 UTC2019-12A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-283f01610625f2…
2019-12-14 00:12 UTC2019-12A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-283f01610625f2…
2019-12-14 00:12 UTC2019-12A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-283f01610625f2…
2019-09-15 20:21 UTC2019-09A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORALAB2013-05-28b00525d2431f…
2019-09-15 20:21 UTC2019-09A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORALAB2013-05-28b00525d2431f…
2019-09-15 20:21 UTC2019-09A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2013-05-28b00525d2431f…
2019-09-15 20:21 UTC2019-09A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORALAB2013-05-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORALAB2013-05-28ea99ee380514…
2019-07-19 19:46 UTC2019-07A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORALAB2013-05-28ea99ee380514…
2019-07-19 19:46 UTC2019-07A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2013-05-28ea99ee380514…
2019-07-19 19:46 UTC2019-07A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORALAB2013-05-28ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A091633-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091633-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091633-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091633-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091633-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091633-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091633-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091633-004AB1ea99ee380514…

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
Hydrocodone Bitartrate and IbuprofenHYDROCODONE BITARTRATE AND IBUPROFENAurolife Pharma, LLC470df63a-5c0f-42df-9023-a330a901153e2025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Ibuprofen
Hydrocodone Bitartrate and IbuprofenHYDROCODONE BITARTRATE AND IBUPROFENAmneal Pharmaceuticals of New York LLCabc33718-4e88-43ea-9ffa-2b04ffc812ef2025-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Ibuprofen

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57664-102Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofenSun Pharmaceutical Industries, Inc.ANDACurrent
57664-203Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofenSun Pharmaceutical Industries, Inc.ANDACurrent
57664-280Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofenSun Pharmaceutical Industries, Inc.ANDACurrent
57664-281Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofenSun Pharmaceutical Industries, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76094ORIG 2023-11-02