Application 205085

Type
ANDA
Sponsor
ORIENT PHARMA CO LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARISOPRODOLCARISOPRODOLTABLET;ORAL350MGNoNo

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
A205085-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA2014-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205085-001AA

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 22:38:342026-08A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-2884e616aacf4f…
2026-08-18 06:07:402026-07A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-283f01610625f2…
2019-09-15 20:21 UTC2019-09A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205085-001CARISOPRODOL350MGTABLET / ORALAA2014-10-28f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205085-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A205085-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205085-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205085-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205085-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205085-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205085-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205085-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205085-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205085-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205085-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205085-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205085-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205085-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205085-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205085-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205085-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205085-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205085-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205085-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205085-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205085-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205085-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A205085-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205085-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205085-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205085-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A205085-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205085-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205085-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205085-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205085-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205085-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205085-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205085-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205085-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205085-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205085-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205085-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205085-001AA1f41ea6bd6efb…

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 2 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarisoprodolCARISOPRODOLMylan Pharmaceuticals Inc.7c9184c0-7a2e-11df-8c8d-0002a5d5c51b2025-07-15Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLGranulation Technology, Inc.2abd11e4-8ce4-4aeb-87c4-3af94c1977142025-06-11Warnings, Adverse reactionsName fallback
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLPD-Rx Pharmaceuticals, Inc.4626a7a7-c433-4dab-8deb-e6e45de493a62025-02-05Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLPD-Rx Pharmaceuticals, Inc.9d251c26-c893-425a-b8ac-20c06e50e80c2025-02-05Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
carisoprodolCARISOPRODOLNuCare Pharmaceuticals,Inc.fd03c357-b199-c2b2-e053-6294a90abe2e2025-02-04Warnings, Adverse reactionsName fallback
brand name: carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLBryant Ranch Prepackf8aee817-c652-441e-b99a-8cbc4e6d06ef2025-02-04Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLBryant Ranch Prepack95e13b8c-3558-43f0-b888-90978db878fb2025-02-03Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLBryant Ranch Prepackacc7f959-55ac-4d9b-8ef4-4538378364e62025-01-24Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLDirect_Rxead8294f-fd27-5c3d-e053-2a95a90a64af2025-01-22Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLAdvanced Rx Pharmacy of Tennessee, LLCf835e66e-f3f3-c3cf-e053-6294a90addf22024-12-31Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLOxford Pharmaceuticals, LLC03c3455f-e217-4a7e-908f-609333dc35fc2024-12-24Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLWilshire Pharmaceuticals, Inc.f03a1ea6-20c1-406a-a5b6-00f1a056d9ff2024-12-13Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
carisoprodolCARISOPRODOLAsclemed USA, Inc.301f5e6a-54e1-4885-b9cb-de475de59b222024-09-12Warnings, Adverse reactionsName fallback
brand name: carisoprodol
generic name: CARISOPRODOL
CARISOPRODOLCARISOPRODOLBryant Ranch Prepackfdd6318f-399f-499c-acdc-5318aa080f362024-08-29Warnings, Adverse reactionsName fallback
brand name: CARISOPRODOL
generic name: CARISOPRODOL
carisoprodolCARISOPRODOLBryant Ranch Prepackb72ac75b-8c7c-4ec4-a7fa-b9c1a18f644c2024-08-29Warnings, Adverse reactionsName fallback
brand name: carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLBryant Ranch Prepack8079db44-70d4-4daf-b4b7-89d0e0f384702024-08-14Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CARISOPRODOLCARISOPRODOLNuCare Pharmaceuticals,Inc.93cbe188-5443-b392-e053-2995a90a9ac72024-06-19Warnings, Adverse reactionsName fallback
brand name: CARISOPRODOL
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLMedsource Pharmaceuticals125023cb-45c2-1685-e063-6394a90af0892024-02-26Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
carisoprodolCARISOPRODOLAurobindo Pharma Limited79637c7b-fe7b-436c-892b-6c36abfdcacc2024-01-06Warnings, Adverse reactionsName fallback
brand name: carisoprodol
generic name: CARISOPRODOL
carisoprodolCARISOPRODOLRising Pharma Holdings, Inc.4d2470cb-7a5d-45f0-b005-534458833d912024-01-06Warnings, Adverse reactionsName fallback
brand name: carisoprodol
generic name: CARISOPRODOL

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 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-510CarisoprodolCarisoprodolNorthStar RxLLCANDACurrent
16714-510CarisoprodolCarisoprodolNorthStar RxLLCANDACurrent
16714-510CarisoprodolCarisoprodolNorthStar RxLLCANDACurrent
43063-824CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, InANDACurrent
43063-824CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-824CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-824CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-824CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-824CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3211CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
50090-3211CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
50090-3232CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
50090-3232CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
50090-4744CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
50090-4746CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
50090-5212CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
50090-5214CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
50436-0451CarisoprodolCarisoprodolUnit Dose ServicesANDACurrent
50436-0705CarisoprodolCarisoprodolUnit Dose ServicesANDACurrent
50436-0705CarisoprodolCarisoprodolUnit Dose ServicesANDACurrent
53217-158CarisoprodolCarisoprodolAidarex Pharmaceuticals LLCANDACurrent
59746-705CarisoprodolCarisoprodolJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-705CarisoprodolCarisoprodolJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-705CarisoprodolCarisoprodolJubilant Cadista Pharmaceuticals Inc.ANDACurrent
60760-705CarisoprodolCarisoprodolSt. Mary's Medical Park PharmacyANDACurrent
60760-705CarisoprodolCarisoprodolSt. Mary's Medical Park PharmacyANDACurrent
61442-451CarisoprodolCarisoprodolCarlsbad Technology, Inc.ANDACurrent
61442-451CarisoprodolCarisoprodolCarlsbad Technology, Inc.ANDACurrent
61442-451CarisoprodolCarisoprodolCarlsbad Technology, Inc.ANDACurrent
61919-979CARISOPRODOLCARISOPRODOLDIRECT RXANDACurrent
61919-979CARISOPRODOLCARISOPRODOLDirect_RxANDACurrent
61919-979CARISOPRODOLCARISOPRODOLDirect_RxANDACurrent
61919-979CARISOPRODOLCARISOPRODOLDirect_RxANDACurrent
61919-979CARISOPRODOLCARISOPRODOLDirect_RxANDACurrent
63187-786CarisoprodolCarisoprodolProficient Rx LPANDACurrent
63187-786CarisoprodolCarisoprodolProficient Rx LPANDACurrent
63187-786CarisoprodolCarisoprodolProficient Rx LPANDACurrent
68071-2188CarisoprodolCarisoprodolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2188CarisoprodolCarisoprodolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4263CarisoprodolCarisoprodolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4263CarisoprodolCarisoprodolNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6866CarisoprodolCarisoprodolPreferred Pharmaceuticals Inc.ANDACurrent
68788-6866CarisoprodolCarisoprodolPreferred Pharmaceuticals Inc.ANDACurrent
70518-2618CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
70518-2618CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
70518-2618CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
71335-0131CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
71335-0131CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
76333-135CarisoprodolCarisoprodolOrient Pharma Co., Ltd.ANDACurrent