FDA.reportPublic FDA data

Application 072296

Type
ANDA
Sponsor
QUANTUM PHARMICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET;ORAL5MGNoNo

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
A072296-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-0884e616aacf4f…
2026-08-18 06:07:402026-07A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072296-001OXYBUTYNIN CHLORIDE5MGTABLET / ORAL1988-12-08f41ea6bd6efb…

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 4 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEBryant Ranch Prepack169d6d58-8887-4bdd-95bd-873d1f049eaa2024-05-24Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEProficient Rx LP7d2332b4-9e48-4bb2-a2c3-75e16e1d455b2024-04-01Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEBryant Ranch Prepack2f898b29-46cf-4427-bb64-8c30532222f52024-01-18Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions5e3b454b-6d3c-418b-8ac2-b0e17f018bbf2023-12-27Warnings, Adverse reactionsName fallback
brand name: Oxybutynin Chloride
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutionsafc6a3aa-e43d-4f10-bdbd-570a149bf9db2023-12-27Warnings, Adverse reactionsName fallback
brand name: Oxybutynin Chloride
generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEA-S Medication Solutions83522acd-0ecc-46ac-a018-a3205ba096ff2023-11-01Warnings, Adverse reactionsName fallback
brand name: OXYBUTYNIN CHLORIDE
generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDENCS HealthCare of KY, LLC dba Vangard Labs5b72d34e-ae57-4459-ba2c-3bae8a69c5c12023-10-04Warnings, Adverse reactionsName fallback
brand name: OXYBUTYNIN CHLORIDE
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2023-05-31Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLCd2bb6927-5fbf-49ca-a891-d701bff1c8122023-05-31Warnings, Adverse reactionsName fallback
brand name: Oxybutynin Chloride
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDELannett Company, Inc.c5950dba-d92b-46a0-993f-af9f9ddb52bf2023-05-30Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAmneal Pharmaceuticals LLC53924eba-1919-4203-9a1e-d57dfdd3b9632023-02-02Warnings, Adverse reactionsName fallback
brand name: Oxybutynin Chloride
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC1e1c1043-e4c5-4a06-9cc1-45d4397746f42023-01-04Warnings, Adverse reactionsName fallback
brand name: Oxybutynin Chloride
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEProficient Rx LPe3f0c249-8085-4979-823a-820e233a284f2022-06-01Warnings, Adverse reactionsName fallback
brand name: Oxybutynin Chloride
generic name: OXYBUTYNIN CHLORIDE
oxybutynin chlorideOXYBUTYNIN CHLORIDEProficient Rx LP88f08450-559e-4038-aad1-051e4ab283cf2022-06-01Warnings, Adverse reactionsName fallback
brand name: oxybutynin chloride
generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDELeading Pharma, LLCb73b8338-8045-448f-87a6-3d289227d00e2022-02-14Warnings, Adverse reactionsName fallback
brand name: OXYBUTYNIN CHLORIDE
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDELannett Company, Inc.615f3d95-197c-4fec-b81f-c26449c93c3b2020-02-21Warnings, Adverse reactionsName fallback
brand name: Oxybutynin Chloride
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLCe985e201-2fb3-4781-9790-a1a3db1ae2a12017-10-20Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC58136f28-70c1-4cf2-bcd7-858c5609431a2016-06-15Warnings, Adverse reactionsName fallback
brand name: Oxybutynin Chloride
generic name: OXYBUTYNIN CHLORIDE

Reported adverse events (FAERS/openFDA)#

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