Application 020938

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOBIC	MELOXICAM	TABLET;ORAL	7.5MG	Yes	No
002	MOBIC	MELOXICAM	TABLET;ORAL	15MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020938-001	MOBIC	MELOXICAM	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-13
N020938-002	MOBIC	MELOXICAM	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-08-23

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020938-001	MOBIC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020938-002	MOBIC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020938-001	MOBIC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020938-002	MOBIC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020938-001	MOBIC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020938-002	MOBIC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020938-001	MOBIC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020938-002	MOBIC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020938-001	MOBIC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020938-002	MOBIC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020938-001	MOBIC	7.5MG	TABLET / ORAL		RLD	2000-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020938-002	MOBIC	15MG	TABLET / ORAL		RLD	2000-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020938-001	MOBIC	7.5MG	TABLET / ORAL		RLD	2000-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020938-002	MOBIC	15MG	TABLET / ORAL		RLD	2000-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020938-001	MOBIC	7.5MG	TABLET / ORAL		RLD	2000-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020938-002	MOBIC	15MG	TABLET / ORAL		RLD	2000-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020938-001	MOBIC	7.5MG	TABLET / ORAL		RLD	2000-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020938-002	MOBIC	15MG	TABLET / ORAL		RLD	2000-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020938-001	MOBIC	7.5MG	TABLET / ORAL		RLD	2000-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020938-002	MOBIC	15MG	TABLET / ORAL		RLD	2000-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020938-001	MOBIC	7.5MG	TABLET / ORAL		RLD	2000-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020938-002	MOBIC	15MG	TABLET / ORAL		RLD	2000-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020938-001	MOBIC	7.5MG	TABLET / ORAL		RLD	2000-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020938-002	MOBIC	15MG	TABLET / ORAL		RLD	2000-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020938-001	MOBIC	7.5MG	TABLET / ORAL		RLD	2000-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020938-002	MOBIC	15MG	TABLET / ORAL		RLD	2000-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020938-001	MOBIC	7.5MG	TABLET / ORAL		RLD	2000-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020938-002	MOBIC	15MG	TABLET / ORAL		RLD	2000-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020938-001	MOBIC	7.5MG	TABLET / ORAL		RLD	2000-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020938-002	MOBIC	15MG	TABLET / ORAL		RLD	2000-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020938-001	MOBIC	7.5MG	TABLET / ORAL		RLD	2000-04-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020938-002	MOBIC	15MG	TABLET / ORAL		RLD	2000-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020938-001	MOBIC	7.5MG	TABLET / ORAL	AB	RLD	2000-04-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020938-002	MOBIC	15MG	TABLET / ORAL	AB	RLD, RS	2000-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020938-001	MOBIC	7.5MG	TABLET / ORAL	AB	RLD	2000-04-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020938-002	MOBIC	15MG	TABLET / ORAL	AB	RLD, RS	2000-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020938-001	MOBIC	7.5MG	TABLET / ORAL	AB	RLD	2000-04-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020938-002	MOBIC	15MG	TABLET / ORAL	AB	RLD, RS	2000-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020938-001	MOBIC	7.5MG	TABLET / ORAL	AB	RLD	2000-04-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020938-002	MOBIC	15MG	TABLET / ORAL	AB	RLD, RS	2000-08-23	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020938-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020938-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020938-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020938-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020938-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020938-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020938-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020938-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020938-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020938-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020938-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020938-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020938-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020938-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020938-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020938-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020938-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020938-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020938-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020938-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020938-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020938-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020938-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020938-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020938-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020938-002	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N020938-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020938-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020938-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020938-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020938-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020938-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020938-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020938-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020938-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020938-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020938-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020938-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020938-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020938-002	AB	1	`3bdfa0b2c4d7…`

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 6 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MELOXICAM	MELOXICAM	Bryant Ranch Prepack	e5860527-f338-4073-9bb4-9f5f079469e7	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	Bryant Ranch Prepack	3e37bece-b23e-41ca-9557-5105087e273b	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Lupin Pharmaceuticals, Inc.	06a401f0-4380-4081-86ed-a309a25abf6b	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	Unichem Pharmaceuticals (USA), Inc.	5fe76337-eae5-4e5c-96ef-6cfa97983c6e	2024-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	NuCare Pharmaceuticals, Inc.	4925f194-c924-242c-e054-00144ff88e88	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	NuCare Pharmaceuticals,Inc.	630221ef-714e-6996-e053-2991aa0a586f	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
MELOXICAM	MELOXICAM	Proficient Rx LP	3cc9741f-0574-485f-bbf5-027cb236736c	2024-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
MELOXICAM	MELOXICAM	AiPing Pharmaceutical, Inc	f93806e1-88b8-4bcd-ac29-7642ab4d6cbd	2024-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	A-S Medication Solutions	eb5834e0-c6db-4d0f-ae37-9ba2e1aabfdf	2023-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	A-S Medication Solutions	bcfca8c6-bdba-4546-97be-1fc5601c7346	2023-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
MELOXICAM	MELOXICAM	NCS HealthCare of KY, LLC dba Vangard Labs	108397e9-672d-4061-bb74-65818c782d61	2023-03-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	Asclemed USA, Inc.	49367275-4bff-4e36-8a91-e59eb07aa15f	2022-10-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Aphena Pharma Solutions - Tennessee, LLC	e1603665-bbce-48b3-9424-3646570ae9b8	2022-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Proficient Rx LP	b5d72a30-3d32-45ad-be81-3fe601d8912b	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Aphena Pharma Solutions - Tennessee, LLC	432c3937-a4fe-4c92-8452-9ed2dd2cfc9a	2022-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Aphena Pharma Solutions - Tennessee, LLC	9392df66-a152-40e6-b43b-44dc46a23496	2021-08-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	Aphena Pharma Solutions - Tennessee, LLC	10c3949c-0066-4b8a-8d35-937e1ce09bf8	2021-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Aphena Pharma Solutions - Tennessee, LLC	8f43b954-d1cb-4210-b479-5292c446cc74	2021-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	Aphena Pharma Solutions - Tennessee, LLC	966ae650-ad7d-4de1-ab06-54992408fcfd	2021-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Aphena Pharma Solutions - Tennessee, LLC	2a29daa9-74e5-4ed6-b5f1-ce04dc411b26	2020-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM

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 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0029	Mobic	meloxicam	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0029	Mobic	meloxicam	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0029	Mobic	meloxicam	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0029	Mobic	meloxicam	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0029	Mobic	meloxicam	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0030	Mobic	meloxicam	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0030	Mobic	meloxicam	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0030	Mobic	meloxicam	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0030	Mobic	meloxicam	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0030	Mobic	meloxicam	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
55289-618	Mobic	meloxicam	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-618	Mobic	meloxicam	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-618	Mobic	meloxicam	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-618	Mobic	meloxicam	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-618	Mobic	meloxicam	PD-Rx Pharmaceuticals, Inc.	NDA	Current
70518-1580	Mobic	meloxicam	REMEDYREPACK INC.	NDA	Current
70518-1580	Mobic	meloxicam	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80381	SUPPL	2024-11-25
80380	SUPPL	2024-11-25
80283	SUPPL	2024-11-22
67353	SUPPL	2021-05-03
67352	SUPPL	2021-05-03
67264	SUPPL	2021-04-30
35685	SUPPL	2016-07-05
26256	SUPPL	2016-07-01
26255	SUPPL	2016-05-12
26254	SUPPL	2016-05-12
35684	SUPPL	2016-05-11
13786	SUPPL	2016-05-11
3811	SUPPL	2012-03-12
35683	SUPPL	2012-03-05
35682	SUPPL	2011-08-05
26253	SUPPL	2011-08-05
26252	SUPPL	2010-08-03
13785	SUPPL	2010-08-01
26251	SUPPL	2010-04-29
13784	SUPPL	2010-04-28
23208	ORIG	2009-11-19
3810	SUPPL	2008-07-01
13783	SUPPL	2008-06-30
35681	SUPPL	2007-02-02
26250	SUPPL	2007-02-02
35680	SUPPL	2005-08-15
26249	SUPPL	2005-08-15
13782	SUPPL	2005-08-15
3809	SUPPL	2005-08-15
35679	SUPPL	2004-07-21
3808	SUPPL	2004-07-21
26248	SUPPL	2003-05-29
13781	SUPPL	2003-05-06
21291	ORIG	2001-07-18
35678	ORIG	2000-04-13
26247	ORIG	2000-04-13
52030	SUPPL	1900-01-01
52029	SUPPL	1900-01-01
52026	SUPPL	1900-01-01