FDA.reportPublic FDA data

Application 201295

Type
ANDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATESOLUTION;ORAL325MG/15ML;7.5MG/15MLNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATESOLUTION;ORAL300MG/15ML;10MG/15MLNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-30
A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-30

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 2 of 2 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-03-09 01:35 UTC2022-03A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2021-12-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALAA2021-12-30bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-306a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-301c564ffb4f44…
2024-02-18 07:12 UTC2024-02A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-30ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-30a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-309b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-30a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-303f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-30053a50430f4f…
2023-05-13 08:27 UTC2023-05A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-303bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-303a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-30f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-30e64feba35796…
2022-09-29 23:25 UTC2022-09A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-30cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201295-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2021-12-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201295-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORAL2021-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A201295-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201295-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201295-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201295-002AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A201295-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201295-002AA1bb7c543d1eb4…

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 acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLC93b6dfdf-ba6e-4ea6-ab85-5ac121e331012026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201295
application number: ANDA201295
ndc (product): 27808-130
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLC57e1fe79-eb60-4f4f-bb38-6df0270d408f2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201295
application number: ANDA201295
ndc (product): 27808-049

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27808-049Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-130hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenTris Pharma IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76481ORIG 2023-11-07