Application 077936

Type: ANDA
Sponsor: HERITAGE PHARMA

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 1.

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
A077936-001	MELOXICAM	MELOXICAM	7.5MG	TABLET / ORAL			2006-07-19
A077936-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077936-001	MELOXICAM	7.5MG	TABLET / ORAL	2006-07-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077936-002	MELOXICAM	15MG	TABLET / ORAL	2006-07-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A077936-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077936-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077936-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077936-002	AB	1	`ea99ee380514…`

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 1 of 6 · 120 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MELOXICAM	MELOXICAM	REMEDYREPACK INC.	f8c35ea4-d6ac-40c7-8f35-864fd1ec75d2	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	5488ccc1-e416-e5d7-e063-6294a90a6cb8	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	548ec3b7-2b6d-cd9e-e063-6394a90a78ff	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	548ef3ed-ab67-ec85-e063-6294a90ab1da	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
QAMZOVA	MELOXICAM	Nanjing Delova Biotech Co., Ltd.	385fd779-1be1-49ae-8213-750b96ecc997	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELOXICAM
meloxicam	MELOXICAM	Coupler LLC	56440abd-80f4-7b8d-e063-6394a90a2a91	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
MELOXICAM	MELOXICAM	REMEDYREPACK INC.	385b7cf4-976a-4a58-9ebc-def8b6e78b75	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
meloxicam	MELOXICAM	HAWAII REPACK, INC.	68b50c82-7130-428a-884c-98576887e99a	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Terrain Pharmaceuticals, Inc.	b603255e-1fcf-42ec-ab62-9aa321cb7ac6	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	REMEDYREPACK INC.	5d153147-f1c8-4624-8028-fe84680d7143	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
MELOXICAM	MELOXICAM	REMEDYREPACK INC.	cdd282df-572f-42a7-a1c6-a00e1bb4573d	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
meloxicam	MELOXICAM	REMEDYREPACK INC.	3e8a6283-1e1b-4199-ac73-f42255c7e907	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	REMEDYREPACK INC.	ffaf1db4-25a9-48d1-a624-242f9d8e14c7	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	St. Mary's Medical Park Pharmacy	b710b959-a64d-a631-e053-2995a90a2177	2026-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Preferred Pharmaceuticals, Inc.	66bc3f93-a73b-476c-83d4-7354d2e18575	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Preferred Pharmaceuticals Inc.	e0deb1f7-b575-463f-a3f8-304cc1936075	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-6568	Meloxicam	Meloxicam	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-6569	Meloxicam	Meloxicam	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
66116-439	Meloxicam	Meloxicam	MedVantx, Inc.	ANDA	Current
66116-443	Meloxicam	Meloxicam	MedVantx, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31307	ORIG	2006-07-21