FDA.reportPublic FDA data

Application 020938

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOBICMELOXICAMTABLET;ORAL7.5MGYesNo
002MOBICMELOXICAMTABLET;ORAL15MGYesYes

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
N020938-001MOBICMELOXICAM7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-13
N020938-002MOBICMELOXICAM15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-08-23

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020938-001MOBIC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-13a50c72e98297…
2026-08-01 22:54:322026-06N020938-002MOBIC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-08-23a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 6 · 120 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELOXICAMMELOXICAMREMEDYREPACK INC.f8c35ea4-d6ac-40c7-8f35-864fd1ec75d22026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLC5488ccc1-e416-e5d7-e063-6294a90a6cb82026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLC548ec3b7-2b6d-cd9e-e063-6394a90a78ff2026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLC548ef3ed-ab67-ec85-e063-6294a90ab1da2026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
QAMZOVAMELOXICAMNanjing Delova Biotech Co., Ltd.385fd779-1be1-49ae-8213-750b96ecc9972026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMCoupler LLC56440abd-80f4-7b8d-e063-6394a90a2a912026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MELOXICAMMELOXICAMREMEDYREPACK INC.385b7cf4-976a-4a58-9ebc-def8b6e78b752026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMHAWAII REPACK, INC.68b50c82-7130-428a-884c-98576887e99a2026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MeloxicamMELOXICAMTerrain Pharmaceuticals, Inc.b603255e-1fcf-42ec-ab62-9aa321cb7ac62026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMREMEDYREPACK INC.5d153147-f1c8-4624-8028-fe84680d71432026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MELOXICAMMELOXICAMREMEDYREPACK INC.cdd282df-572f-42a7-a1c6-a00e1bb4573d2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMREMEDYREPACK INC.3e8a6283-1e1b-4199-ac73-f42255c7e9072026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMREMEDYREPACK INC.ffaf1db4-25a9-48d1-a624-242f9d8e14c72026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMSt. Mary's Medical Park Pharmacyb710b959-a64d-a631-e053-2995a90a21772026-06-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMPreferred Pharmaceuticals, Inc.66bc3f93-a73b-476c-83d4-7354d2e185752026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMPreferred Pharmaceuticals Inc.e0deb1f7-b575-463f-a3f8-304cc19360752026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MELOXICAMMELOXICAMRedpharm Drug5407aded-9f84-72ce-e063-6394a90ae6722026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MELOXICAMMELOXICAMSt. Mary's Medical Park Pharmacyfbe71312-0f9d-47c1-e053-6394a90a63a12026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMSt. Mary's Medical Park Pharmacy60c954d5-bd5a-33f9-e053-2a91aa0ab5972026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MeloxicamMELOXICAMEmerald Therapeutics, LLC55af77dd-2abc-49a6-990c-399d5a5e7a912026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0029MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0029MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0029MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0029MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0029MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0030MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0030MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0030MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0030MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0030MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
55289-618MobicmeloxicamPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-618MobicmeloxicamPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-618MobicmeloxicamPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-618MobicmeloxicamPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-618MobicmeloxicamPD-Rx Pharmaceuticals, Inc.NDACurrent
70518-1580MobicmeloxicamREMEDYREPACK INC.NDACurrent
70518-1580MobicmeloxicamREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80381SUPPL 2024-11-25
80380SUPPL 2024-11-25
80283SUPPL 2024-11-22
67353SUPPL2021-05-03
67352SUPPL2021-05-03
67264SUPPL2021-04-30
35685SUPPL2016-07-05
26256SUPPL2016-07-01
26255SUPPL2016-05-12
26254SUPPL2016-05-12
35684SUPPL2016-05-11
13786SUPPL2016-05-11
3811SUPPL2012-03-12
35683SUPPL2012-03-05
35682SUPPL2011-08-05
26253SUPPL2011-08-05
26252SUPPL2010-08-03
13785SUPPL2010-08-01
26251SUPPL2010-04-29
13784SUPPL2010-04-28
23208ORIG2009-11-19
3810SUPPL2008-07-01
13783SUPPL2008-06-30
35681SUPPL2007-02-02
26250SUPPL2007-02-02
35680SUPPL2005-08-15
26249SUPPL2005-08-15
13782SUPPL2005-08-15
3809SUPPL2005-08-15
35679SUPPL2004-07-21
3808SUPPL2004-07-21
26248SUPPL2003-05-29
13781SUPPL2003-05-06
21291ORIG2001-07-18
35678ORIG2000-04-13
26247ORIG2000-04-13
52030SUPPL1900-01-01
52029SUPPL1900-01-01
52026SUPPL1900-01-01