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 5 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
meloxicam	MELOXICAM	PD-Rx Pharmaceuticals, Inc.	4acea0aa-973f-40e5-88b4-0e2d85ea624c	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Preferred Pharmaceuticals Inc.	ef3447a9-ed6a-4cba-9681-09ae9dc8b630	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	af9cf496-d505-f2ba-e053-2995a90a76cf	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	af9d0426-9cbb-a6a3-e053-2995a90aed2f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	af9cde70-6c74-f6a8-e053-2995a90addaf	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	af9cb78a-e61b-b099-e053-2a95a90a3ad8	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	b33bf17a-3134-6f32-e053-2a95a90a261b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
MELOXICAM	MELOXICAM	Aphena Pharma Solutions - Tennessee, LLC	29b9c956-4146-6941-e063-6394a90aa3c8	2024-12-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
Meloxicam	MELOXICAM	Quality Care Products LLC	aa28251e-cab0-49a2-bf3f-ad820b1432cf	2024-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Quality Care Products LLC	0edec862-f3e8-46f6-b6d0-de0bc21dd3fb	2024-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	A-S Medication Solutions	7df126c1-a729-4bfe-9d08-ad359c9ee3bc	2024-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Zydus Lifesciences Limited	5eb2e439-2ef2-496c-9aec-042029ae1305	2024-11-30		Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Bryant Ranch Prepack	37c030e7-f4f0-4923-847e-85325265960a	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Bryant Ranch Prepack	c51a641b-5715-4be9-baac-7fd4ec729570	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	XLCare Pharmaceuticals, Inc.	50ecda86-d46b-4a78-b423-879f9f5c42bd	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Quallent Pharmaceuticals Health LLC	2875c30d-508a-46e1-ae5a-bc7057e7cbee	2024-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Zydus Pharmaceuticals USA Inc.	6c015f72-5ce3-4f56-8237-776fc2165b0c	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Bryant Ranch Prepack	a381942f-0cba-4e97-4741-ad04a6af2164	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
MELOXICAM	MELOXICAM	NuCare Pharmaceuticals, Inc.	43ca4ab6-7d52-2954-e054-00144ff88e88	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
MELOXICAM	MELOXICAM	Camber Pharmaceuticals, Inc.	5265e241-ab6a-400f-809f-5992f36c5593	2024-08-16	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