FDA.reportPublic FDA data

Application 207635

Type
ANDA
Sponsor
CNTY LINE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITALTABLET;ORAL300MG;50MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207635-001BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITAL300MG;50MGTABLET / ORAL2017-06-05

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A207635-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGTABLET / ORALAA2017-06-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207635-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGTABLET / ORALAA2017-06-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207635-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGTABLET / ORAL2017-06-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207635-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207635-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207635-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207635-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207635-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207635-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207635-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A207635-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207635-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207635-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207635-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A207635-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207635-001AA1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207635-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207635-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207635-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207635-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207635-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207635-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207635-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207635-001AA1cb3db0bc1861…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
butalbital and acetaminophenBUTALBITAL AND ACETAMINOPHENPar Healthe619b656-4123-4878-b601-b0edad3c428b2026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: butalbital and acetaminophen
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENAmici Pharma, Inc.3280501f-928a-4112-803d-fb9771c865472026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL AND ACETAMINOPHEN
Butalbital And AcetaminophenBUTALBITAL AND ACETAMINOPHENLarken Laboratories, Inc.326c83fc-afed-45ad-9c87-f47968fa1d2a2025-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital And Acetaminophen
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENAarkish Pharmaceuticals NJ Inc.82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a62025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL AND ACETAMINOPHEN
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENBurel Pharmaceuticals, LLC0a8a6a16-b23f-45d2-b5d4-540264e74d142024-10-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL AND ACETAMINOPHEN
butalbital and acetaminophenBUTALBITAL AND ACETAMINOPHENDr. Reddy's Labratories Inc.42d808d6-d8d4-22f5-ac2f-0f0d1d71686a2024-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: butalbital and acetaminophen
BUTALBITAL and ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENQUAGEN PHARMACEUTICALS LLC1f0dbe62-6aea-4323-ad25-c2211f9192532024-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL and ACETAMINOPHEN
BUTALBITAL and ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENQUAGEN PHARMACEUTICALS LLC2eb09253-7f59-401e-afbc-70bb9600fedf2024-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL and ACETAMINOPHEN
butalbital and acetaminophenBUTALBITAL AND ACETAMINOPHENGranules Pharmaceuticals Inc.2091c292-b77b-4ce6-8bba-436c74eee3d72023-02-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: butalbital and acetaminophen
Butalbital and AcetaminophenBUTALBITAL AND ACETAMINOPHEN TABLETSOceanside Pharmaceuticalsd2213ffd-18f6-45f5-9af7-690a977562c42020-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital and Acetaminophen

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-534butalbital and acetaminophenbutalbital and acetaminophenAlvogen Inc.ANDACurrent
47781-534butalbital and acetaminophenbutalbital and acetaminophenAlvogen Inc.ANDACurrent
47781-534butalbital and acetaminophenbutalbital and acetaminophenAlvogen Inc.ANDACurrent
47781-644butalbital and acetaminophenbutalbital and acetaminophenAlvogen Inc.ANDACurrent
47781-644butalbital and acetaminophenbutalbital and acetaminophenAlvogen Inc.ANDACurrent