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N020938-001	MOBIC	MELOXICAM	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-13
N020938-002	MOBIC	MELOXICAM	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-08-23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N020938-001	MOBIC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020938-002	MOBIC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020938-001	MOBIC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020938-002	MOBIC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-08-23	`caaa826d4ba7…`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 4 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
meloxicam	MELOXICAM	PHOENIX RX LLC	3ff222f1-3fe2-9591-e063-6394a90a349f	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	American Health Packaging	937ea2ca-6b8c-4c80-9926-f4de7c8f5643	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Lupin Pharmaceuticals, Inc.	43e2b0f3-cf34-4f51-aa93-39ed98cab449	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	AvPAK	ee8df8fa-d08a-8c8b-f048-813e5022a101	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	PHOENIX RX LLC	3ede6724-d9be-5b44-e063-6294a90afbaa	2025-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
MELOXICAM	MELOXICAM	Cipla USA Inc.	bb83cd61-0a82-4fe0-b72e-5b715cbd656d	2025-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
MELOXICAM	MELOXICAM	PHOENIX RX LLC	3b1938e5-7a9e-b214-e063-6394a90a1270	2025-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
XIFYRM	MELOXICAM	Azurity Pharmaceuticals, Inc.	bf2b198c-0726-488a-b911-4fe394e4b56e	2025-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	ANI Pharmaceuticals, Inc.	ce9a8fd7-9bd2-4793-82f3-0fb8f0965d0f	2025-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
MELOXICAM	MELOXICAM	Asclemed USA, Inc.	6d7ede5a-c12e-4979-a47a-f3346ea5bc80	2025-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Carlsbad Technology, Inc.	20871c7f-1e36-49ef-8e2b-70112430ca1e	2025-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Bryant Ranch Prepack	d3182622-4b9b-4850-bf9f-108c5610eb40	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Bryant Ranch Prepack	ed9c8c21-1d08-4afa-9cd2-3fd8b2a83baf	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Bryant Ranch Prepack	75af3e09-f510-45a4-9f21-50bff7aa5510	2025-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Bryant Ranch Prepack	218e71c6-265a-45f4-b660-5c1da5a36bd2	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
Meloxicam	MELOXICAM	Aurobindo Pharma Limited	d5e12448-1ca1-46a4-8de4-e8b94567e5a8	2025-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
MELOXICAM	MELOXICAM	Aphena Pharma Solutions - Tennessee, LLC	2eaac8b2-d50a-a0bc-e063-6294a90a7cac	2025-02-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	A-S Medication Solutions	29974b41-68b4-42cf-8835-18ae480c2952	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	Asclemed USA, Inc.	4dc34489-cbb6-4e57-a2cc-a274209456f3	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
MELOXICAM	MELOXICAM	PD-Rx Pharmaceuticals, Inc.	25b742d8-5a95-9ec8-e063-6294a90a89ae	2025-01-03	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