Application 077918

Type
ANDA
Sponsor
YUNG SHIN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MELOXICAMMELOXICAMTABLET;ORAL7.5MGNoNo
002MELOXICAMMELOXICAMTABLET;ORAL15MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077918-001MELOXICAMMELOXICAM7.5MGTABLET / ORALAB2006-12-07
A077918-002MELOXICAMMELOXICAM15MGTABLET / ORALAB2006-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077918-001AB
A077918-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07782e0a99824c…
2021-12-28 21:50 UTC2021-12A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077918-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077918-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077918-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077918-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077918-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077918-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077918-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077918-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077918-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077918-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077918-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077918-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077918-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077918-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077918-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077918-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077918-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077918-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077918-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077918-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077918-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077918-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077918-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077918-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077918-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077918-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077918-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077918-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077918-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077918-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077918-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077918-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077918-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077918-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077918-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077918-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077918-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077918-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077918-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077918-002AB1782e0a99824c…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MeloxicamMELOXICAMPD-Rx Pharmaceuticals, Inc.1ab45be4-b2b9-4374-95ab-620e0f90fb702026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 43063-395
MeloxicamMELOXICAMPD-Rx Pharmaceuticals, Inc.eae60d2c-411c-460a-b673-05b5784ed9432026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 43063-396
MeloxicamMELOXICAMGolden State Medical Supply, Inc.d27feaf7-731e-1a8f-e053-2a95a90afa712026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 51407-611
ndc (product): 51407-610
MeloxicamMELOXICAMAvPAKee8df8fa-d08a-8c8b-f048-813e5022a1012025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 50268-525
ndc (product): 50268-526
MeloxicamMELOXICAMCarlsbad Technology, Inc.20871c7f-1e36-49ef-8e2b-70112430ca1e2025-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 61442-127
ndc (product): 61442-126
MeloxicamMELOXICAMBryant Ranch Prepackd3182622-4b9b-4850-bf9f-108c5610eb402025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMBryant Ranch Prepacked9c8c21-1d08-4afa-9cd2-3fd8b2a83baf2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 71335-1888
MeloxicamMELOXICAMBryant Ranch Prepack75af3e09-f510-45a4-9f21-50bff7aa55102025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 63629-3248
MeloxicamMELOXICAMBryant Ranch Prepack218e71c6-265a-45f4-b660-5c1da5a36bd22025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 63629-2019
MeloxicamMELOXICAMAphena Pharma Solutions - Tennessee, LLCe1603665-bbce-48b3-9424-3646570ae9b82022-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 71610-657
MeloxicamMELOXICAMProficient Rx LPb5d72a30-3d32-45ad-be81-3fe601d8912b2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 71205-923
ndc (product): 71205-924
MeloxicamMELOXICAMAphena Pharma Solutions - Tennessee, LLC8f43b954-d1cb-4210-b479-5292c446cc742021-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 71610-542
MeloxicamMELOXICAMAphena Pharma Solutions - Tennessee, LLC2a29daa9-74e5-4ed6-b5f1-ce04dc411b262020-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
ndc (product): 43353-979

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 60 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-6841MeloxicamMeloxicamLiberty Pharmaceuticals, Inc.ANDACurrent
10544-052MeloxicamMeloxicamBlenheim Pharmacal, Inc.ANDACurrent
10544-090MeloxicamMeloxicamBlenheim Pharmacal, Inc.ANDACurrent
43063-395MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-395MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-395MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-395MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-395MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-395MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-395MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-396MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-396MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-396MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-396MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-396MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-396MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-396MeloxicamMeloxicamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-979MeloxicamMeloxicamAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-979MeloxicamMeloxicamAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-426MeloxicamMeloxicamMedsource PharmaceuticalsANDACurrent
50268-525MeloxicamMeloxicamAvPAKANDACurrent
50268-525MeloxicamMeloxicamAvPAKANDACurrent
50268-526MeloxicamMeloxicamAvPAKANDACurrent
50268-526MeloxicamMeloxicamAvPAKANDACurrent
51407-610MeloxicamMeloxicamGolden State Medical Supply, Inc.ANDACurrent
51407-610MeloxicamMeloxicamGolden State Medical Supply, Inc.ANDACurrent
51407-611MeloxicamMeloxicamGolden State Medical Supply, Inc.ANDACurrent
51407-611MeloxicamMeloxicamGolden State Medical Supply, Inc.ANDACurrent
61442-126MeloxicamMeloxicamCarlsbad Technology, Inc.ANDACurrent
61442-126MeloxicamMeloxicamCarlsbad Technology, Inc.ANDACurrent
61442-127MeloxicamMeloxicamCarlsbad Technology, Inc.ANDACurrent
61442-127MeloxicamMeloxicamCarlsbad Technology, Inc.ANDACurrent
63629-2019MeloxicamMeloxicamBryant Ranch PrepackANDACurrent
63629-2019MeloxicamMeloxicamBryant Ranch PrepackANDACurrent
63629-2020MeloxicamMeloxicamBryant Ranch PrepackANDACurrent
63629-2020MeloxicamMeloxicamBryant Ranch PrepackANDACurrent
63629-3248MeloxicamMeloxicamBryant Ranch PrepackANDACurrent
63629-3248MeloxicamMeloxicamBryant Ranch PrepackANDACurrent
63629-3248MeloxicamMeloxicamBryant Ranch PrepackANDACurrent
63629-3248MeloxicamMeloxicamBryant Ranch PrepackANDACurrent
64205-126MeloxicamMeloxicamReadyMedsANDACurrent
64205-127MeloxicamMeloxicamReadyMedsANDACurrent
66336-099MeloxicamMeloxicamDispensing Solutions, Inc.ANDACurrent
66336-774MeloxicamMeloxicamDispensing Solutions, Inc.ANDACurrent
69336-101MeloxicamMeloxicamSTERLING KNIGHT PHARMACEUTICALS, LLCANDACurrent
69336-102MeloxicamMeloxicamSTERLING KNIGHT PHARMACEUTICALS, LLCANDACurrent
70934-030MeloxicamMeloxicamDenton Pharma, Inc. DBA NANDACurrent
70934-030MeloxicamMeloxicamDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-030MeloxicamMeloxicamDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-030MeloxicamMeloxicamDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-297MeloxicamMeloxicamDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-297MeloxicamMeloxicamDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-923MeloxicamMeloxicamProficient Rx LPANDACurrent
71205-923MeloxicamMeloxicamProficient Rx LPANDACurrent
71205-924MeloxicamMeloxicamProficient Rx LPANDACurrent
71205-924MeloxicamMeloxicamProficient Rx LPANDACurrent
71335-1888MeloxicamMeloxicamBryant Ranch PrepackANDACurrent
71610-380MeloxicamMeloxicamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-542MeloxicamMeloxicamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-657MeloxicamMeloxicamAphena Pharma Solutions - Tennessee, LLCANDACurrent