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 2 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MELOXICAM	MELOXICAM	Redpharm Drug	5407aded-9f84-72ce-e063-6394a90ae672	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
MELOXICAM	MELOXICAM	St. Mary's Medical Park Pharmacy	fbe71312-0f9d-47c1-e053-6394a90a63a1	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
meloxicam	MELOXICAM	St. Mary's Medical Park Pharmacy	60c954d5-bd5a-33f9-e053-2a91aa0ab597	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Emerald Therapeutics, LLC	55af77dd-2abc-49a6-990c-399d5a5e7a91	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Avondale Pharmaceuticals, LLC	4ddf5a4d-8e84-419d-8e3a-c91b85501885	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	St. Mary's Medical Park Pharmacy	60c9ab35-4b6e-383d-e053-2a91aa0a26ad	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Coupler LLC	52bd9bcd-4902-f9dd-e063-6294a90a604e	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	REMEDYREPACK INC.	fabd063a-d3a5-44a3-90a2-e33d721b7a95	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Proficient Rx LP	459bd9c0-1102-46d3-8020-5fec80d1ec36	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	PD-Rx Pharmaceuticals, Inc.	1ab45be4-b2b9-4374-95ab-620e0f90fb70	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	PD-Rx Pharmaceuticals, Inc.	eae60d2c-411c-460a-b673-05b5784ed943	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Coupler LLC	5071e1fd-5321-42cf-e063-6294a90a0ef6	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
MELOXICAM	MELOXICAM	Medcore LLC	1160b6a8-d507-40b6-925b-25bf186daa30	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
meloxicam	MELOXICAM	PD-Rx Pharmaceuticals, Inc.	1d8b617a-b9b3-473c-be9b-f34a585a1b3b	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
MELOXICAM	MELOXICAM	Direct Rx	c172a767-eb26-4995-b2a2-f3c5e87b4943	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	af9ce58c-3cd7-769f-e053-2a95a90a5385	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Golden State Medical Supply, Inc.	d27feaf7-731e-1a8f-e053-2a95a90afa71	2026-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
MELOXICAM	MELOXICAM	A-S Medication Solutions	fe41eca5-33f1-4ded-a177-d8f927f3f261	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
MELOXICAM	MELOXICAM	A-S Medication Solutions	2cc0c4c2-eac9-4820-942a-6c606dfb4aa1	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
MELOXICAM	MELOXICAM	A-S Medication Solutions	7a4212a8-7761-4a77-aa18-ecf1f1244df2	2026-02-08	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