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