Application 204770

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METAXALONEMETAXALONETABLET;ORAL800MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204770-001METAXALONEMETAXALONE800MGTABLET / ORALAB2016-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204770-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A204770-001METAXALONE800MGTABLET / ORALAB2016-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204770-001METAXALONE800MGTABLET / ORALAB2016-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204770-001METAXALONE800MGTABLET / ORALAB2016-11-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204770-001METAXALONE800MGTABLET / ORALAB2016-11-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204770-001METAXALONE800MGTABLET / ORALAB2016-11-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204770-001METAXALONE800MGTABLET / ORALAB2016-11-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204770-001METAXALONE800MGTABLET / ORALAB2016-11-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204770-001METAXALONE800MGTABLET / ORALAB2016-11-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204770-001METAXALONE800MGTABLET / ORALAB2016-11-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204770-001METAXALONE800MGTABLET / ORALAB2016-11-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A204770-001METAXALONE800MGTABLET / ORALAB2016-11-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-223f01610625f2…
2019-09-15 20:21 UTC2019-09A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204770-001METAXALONE800MGTABLET / ORALAB2016-11-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204770-001METAXALONE800MGTABLET / ORALAB2016-11-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204770-001METAXALONE800MGTABLET / ORALAB2016-11-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204770-001METAXALONE800MGTABLET / ORALAB2016-11-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A204770-001METAXALONE800MGTABLET / ORALAB2016-11-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204770-001METAXALONE800MGTABLET / ORALAB2016-11-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204770-001METAXALONE800MGTABLET / ORALAB2016-11-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204770-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204770-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204770-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204770-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204770-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204770-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204770-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204770-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204770-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204770-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204770-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204770-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204770-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204770-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204770-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204770-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204770-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204770-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204770-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204770-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204770-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204770-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204770-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204770-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204770-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204770-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204770-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204770-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204770-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204770-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204770-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204770-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204770-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204770-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204770-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204770-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204770-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204770-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204770-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204770-001AB1e64feba35796…

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetaxaloneMETAXALONEREMEDYREPACK INC.e9e45029-b1a4-435f-b9ca-cdfa01051bc82026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 70518-0771
MetaxaloneMETAXALONEPreferred Pharmaceuticals, Inc.1541da6a-7681-40bc-b67e-28e02a950d722026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 68788-7675
MetaxaloneMETAXALONEDirect_Rx8c3bc0a2-5c93-e1d6-e053-2995a90a0b832026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 61919-832
METAXALONEMETAXALONEDIRECT RX9b7b4fc3-3f38-db66-e053-2995a90aaadb2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 61919-832
MetaxaloneMETAXALONEDirect_Rx91432cd0-8404-8029-e053-2a95a90adc1b2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 61919-832
MetaxaloneMETAXALONESt. Mary's Medical Park Pharmacya23ca660-b066-1396-e053-2a95a90a30b22026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 60760-289
MetaxaloneMETAXALONESportpharm LLC3e7efad7-2752-4f7d-ba30-40f17d13e4c32026-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
METAXALONEMETAXALONEDIRECT RX49250bbf-fbfe-07cd-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 61919-832
MetaxaloneMETAXALONENorthwind Health Company, LLCd9cefc55-7643-ce9b-e053-2a95a90aff122026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEA-S Medication Solutionsd4caa7c6-afb5-43a2-ba38-cf30106b1d622025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 50090-3650
MetaxaloneMETAXALONEPHOENIX RX LLC413b300d-4163-afef-e063-6394a90a618f2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEAdvanced Rx Pharmacy of Tennessee, LLCb713a0f2-d47a-0ae7-e053-2995a90a5b852024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 80425-0122
MetaxaloneMETAXALONEQuality Care Products, LLCf05bb280-6736-4215-be5b-0e5f7991cd872024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 55700-494
MetaxaloneMETAXALONEBryant Ranch Prepacka12304b7-6477-4518-8db5-898879c62caf2024-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
MetaxaloneMETAXALONEBryant Ranch Prepacka662fd07-2896-4cbb-bafc-aa5ab179a1482024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 71335-2066
MetaxaloneMETAXALONEBryant Ranch Prepack7f758053-2367-4c5f-9bbd-ce8ce263a6152024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 71335-0958
MetaxaloneMETAXALONEBryant Ranch Prepackc86862a4-f6ff-4268-bec6-35dedbe4cd4a2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 63629-2097
MetaxaloneMETAXALONELannett Company, Inc.8294bb3c-c8eb-474c-b567-e53cf81249e92024-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 0527-1435
MetaxaloneMETAXALONEA-S Medication Solutionsef47682d-ea41-465e-aa21-cc773d45a6f02023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 50090-3670
MetaxaloneMETAXALONEAsclemed USA, Inc.02c42f72-5d78-436d-8105-8c0f8d4c0d912022-07-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204770
application number: ANDA204770
ndc (product): 76420-232

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1435MetaxaloneMetaxaloneLannett Company, Inc.ANDACurrent
0527-1435MetaxaloneMetaxaloneLannett Company, Inc.ANDACurrent
0527-1435MetaxaloneMetaxaloneLannett Company, Inc.ANDACurrent
0527-1435MetaxaloneMetaxaloneLannett Company, Inc.ANDACurrent
45865-942MetaxaloneMetaxalonemedsource pharmaceuticalsANDACurrent
50090-3650MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3650MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3650MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3650MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3650MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3670MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3670MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
55700-494MetaxaloneMetaxaloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-494MetaxaloneMetaxaloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-494MetaxaloneMetaxaloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-494MetaxaloneMetaxaloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-494MetaxaloneMetaxaloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-289MetaxaloneMetaxaloneSt. Mary's Medical Park PharmacyANDACurrent
60760-289MetaxaloneMetaxaloneSt. Mary's Medical Park PharmacyANDACurrent
60760-289MetaxaloneMetaxaloneSt. Mary's Medical Park PharmacyANDACurrent
61919-832METAXALONEMETAXALONEDIRECT RXANDACurrent
61919-832MetaxaloneMetaxaloneDirect_RxANDACurrent
61919-832MetaxaloneMetaxaloneDirect_RxANDACurrent
61919-832METAXALONEMETAXALONEDIRECT RXANDACurrent
61919-832METAXALONEMETAXALONEDIRECT RXANDACurrent
63629-2097MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
63629-2097MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
68071-2849MetaxaloneMetaxaloneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7675MetaxaloneMetaxalonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7675MetaxaloneMetaxalonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7675MetaxaloneMetaxalonePreferred Pharmaceuticals, Inc.ANDACurrent
69306-311MetaxaloneMetaxaloneDoc RxANDACurrent
70332-330MetaxaloneMetaxaloneCalifornia Pharmaceuticals, LLCANDACurrent
70518-0771MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70518-0771MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70518-0771MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70518-0771MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70518-0771MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70934-286MetaxaloneMetaxaloneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-286MetaxaloneMetaxaloneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-286MetaxaloneMetaxaloneDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-426MetaxaloneMetaxaloneProficient Rx LPANDACurrent
71205-426MetaxaloneMetaxaloneProficient Rx LPANDACurrent
71205-426MetaxaloneMetaxaloneProficient Rx LPANDACurrent
71335-0958MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-0958MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-0958MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-1696MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-1696MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-2066MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
76420-232MetaxaloneMetaxaloneAsclemed USA, Inc.ANDACurrent
80425-0122SkelaxinMetaxalone 800mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0122MetaxaloneMetaxaloneAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0122MetaxaloneMetaxaloneAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent