Application 207138

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL5MGNoNo
002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo
003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL15MGNoYes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207138-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29
A207138-002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29
A207138-003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207138-001AB
A207138-002AB
A207138-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207138-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-02-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207138-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2016-02-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207138-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-02-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207138-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207138-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207138-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207138-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207138-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207138-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207138-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207138-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207138-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207138-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207138-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207138-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207138-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207138-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207138-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207138-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207138-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207138-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207138-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207138-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207138-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207138-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207138-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207138-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207138-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207138-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207138-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207138-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207138-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207138-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207138-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207138-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207138-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207138-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207138-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207138-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207138-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207138-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207138-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207138-001AB18072bd15b7f6…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oxybutynin chlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepack7db4ab81-b379-4a6d-b469-95eb9e184b562026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207138
application number: ANDA207138
oxybutynin chlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.a1f8be75-2eb9-4eef-8fb4-144ef2bf7ae12026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207138
application number: ANDA207138
ndc (product): 72789-049
oxybutynin chlorideOXYBUTYNIN CHLORIDEAccord Healthcare, Inc.61496a1e-17bf-4f45-a20c-5bb98fe545ee2025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207138
application number: ANDA207138
ndc (product): 16729-319
ndc (product): 16729-317
ndc (product): 16729-318
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEdirect rxb3d6d2a8-97c4-5bad-e053-2a95a90a155d2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207138
application number: ANDA207138
ndc (product): 72189-131
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEDIRECT RXada3be87-2cdd-75f7-e053-2995a90aa95b2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207138
application number: ANDA207138
ndc (product): 72189-132
oxybutynin chlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions7593becc-250f-4d25-8401-a9f72f3f5ad42024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207138
application number: ANDA207138
ndc (product): 50090-5822
oxybutynin chlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions8f147f73-cfc6-40a3-b1a3-e4cab18685232024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207138
application number: ANDA207138
ndc (product): 50090-4307
oxybutynin chlorideOXYBUTYNIN CHLORIDEProficient Rx LP88f08450-559e-4038-aad1-051e4ab283cf2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207138
application number: ANDA207138
ndc (product): 71205-667

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-317oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-317oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-317oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-318oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-318oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-318oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-319oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-319oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-319oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
50090-4307oxybutynin chlorideoxybutynin chlorideA-S Medication SolutionsANDACurrent
50090-4307oxybutynin chlorideoxybutynin chlorideA-S Medication SolutionsANDACurrent
50090-4307oxybutynin chlorideoxybutynin chlorideA-S Medication SolutionsANDACurrent
50090-5822oxybutynin chlorideoxybutynin chlorideA-S Medication SolutionsANDACurrent
55700-647oxybutynin chlorideoxybutynin chlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-647oxybutynin chlorideoxybutynin chlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
68788-7109oxybutynin chlorideoxybutynin chloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7109oxybutynin chlorideoxybutynin chloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7109oxybutynin chlorideoxybutynin chloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0158oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2388oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2388oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2388oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2388oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2710oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2710oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2710oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-3032oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
71205-667oxybutynin chlorideoxybutynin chlorideProficient Rx LPANDACurrent
71335-0610oxybutynin chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
71335-0610oxybutynin chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
71335-0610oxybutynin chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
72189-131OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEdirect rxANDACurrent
72189-132OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEDIRECT RXANDACurrent
72789-049oxybutynin chlorideoxybutynin chloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-049oxybutynin chlorideoxybutynin chloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-049oxybutynin chlorideoxybutynin chloridePD-Rx Pharmaceuticals, Inc.ANDACurrent