Application 077925

Type: ANDA
Sponsor: ROXANE

Application Products#

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

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
A077925-001	MELOXICAM	MELOXICAM	7.5MG	TABLET / ORAL			2006-07-19
A077925-002	MELOXICAM	MELOXICAM	15MG	TABLET / ORAL			2006-07-19

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077925-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077925-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`74a2ff9319b5…`

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 brand name: MELOXICAM generic name: MELOXICAM
meloxicam	MELOXICAM	Bryant Ranch Prepack	3e37bece-b23e-41ca-9557-5105087e273b	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Lupin Pharmaceuticals, Inc.	06a401f0-4380-4081-86ed-a309a25abf6b	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Unichem Pharmaceuticals (USA), Inc.	5fe76337-eae5-4e5c-96ef-6cfa97983c6e	2024-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	NuCare Pharmaceuticals, Inc.	4925f194-c924-242c-e054-00144ff88e88	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	NuCare Pharmaceuticals,Inc.	630221ef-714e-6996-e053-2991aa0a586f	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
MELOXICAM	MELOXICAM	Proficient Rx LP	3cc9741f-0574-485f-bbf5-027cb236736c	2024-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
MELOXICAM	MELOXICAM	AiPing Pharmaceutical, Inc	f93806e1-88b8-4bcd-ac29-7642ab4d6cbd	2024-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
meloxicam	MELOXICAM	A-S Medication Solutions	eb5834e0-c6db-4d0f-ae37-9ba2e1aabfdf	2023-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	A-S Medication Solutions	bcfca8c6-bdba-4546-97be-1fc5601c7346	2023-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam 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 brand name: MELOXICAM generic name: MELOXICAM
meloxicam	MELOXICAM	Asclemed USA, Inc.	49367275-4bff-4e36-8a91-e59eb07aa15f	2022-10-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam 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 brand name: Meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Proficient Rx LP	b5d72a30-3d32-45ad-be81-3fe601d8912b	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam 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 brand name: Meloxicam 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 brand name: Meloxicam 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 brand name: meloxicam 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 brand name: Meloxicam 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 brand name: meloxicam 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 brand name: Meloxicam generic name: MELOXICAM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9094	ORIG	2006-07-21