Application 077938

Type: ANDA
Sponsor: PURACAP PHARM

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
A077938-001	MELOXICAM	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19
A077938-002	MELOXICAM	MELOXICAM	15MG	TABLET / ORAL	AB		2006-07-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077938-001	AB
A077938-002	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077938-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077938-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077938-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077938-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077938-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077938-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077938-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077938-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077938-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077938-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077938-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077938-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077938-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077938-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077938-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077938-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077938-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077938-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077938-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077938-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077938-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077938-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077938-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077938-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077938-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077938-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077938-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077938-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077938-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077938-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077938-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077938-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077938-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077938-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077938-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077938-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077938-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077938-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077938-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077938-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077938-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077938-002	AB	1	`782e0a99824c…`

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 3 of 6 · 120 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MELOXICAM	MELOXICAM	PD-Rx Pharmaceuticals, Inc.	19c13159-71f1-2427-e063-6394a90ad44e	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
meloxicam	MELOXICAM	Preferred Pharmaceuticals Inc.	c6f37980-8e09-4f2e-a768-b3d22cbe3d49	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Northwind Health Company, LLC	3ce43f4a-c525-4ce1-b328-514b3912e305	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	Northwind Health Company, LLC	820f143f-4b0c-4466-be9a-212dab9d984b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
MELOXICAM	MELOXICAM	Northwind Health Company, LLC	f2b42bdc-47e1-19c5-e053-2a95a90a1828	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
MELOXICAM	MELOXICAM	Northwind Health Company, LLC	f31d181a-33cb-560f-e053-2995a90abbd9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
Meloxicam	MELOXICAM	Chartwell RX, LLC	8bd53770-7077-49c7-8215-73a17a20ea70	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
MELOXICAM	MELOXICAM	AiPing Pharmaceutical, Inc	ac58edaa-4aba-4fa8-9ccd-f33477aee218	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
MELOXICAM	MELOXICAM	XLCare Pharmaceuticals, Inc.	702a4aa6-a588-48db-9cc5-74ae417f9587	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	445d7cbf-bd3e-a54f-e063-6294a90a67a5	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	445dc4f6-daac-e2f1-e063-6394a90a0ca5	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	PHOENIX RX LLC	438311de-78e7-8bd9-e063-6394a90a7932	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	453c5328-090e-0159-e063-6394a90a06b7	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	QPharma, Inc.	20ec4646-9d1c-41c9-93f6-754b3a4f234f	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	A-S Medication Solutions	67974608-326e-4e62-8430-6fbc14d1d69b	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	NuCare Pharmaceuticals,Inc.	87ef5a9b-2dd1-2ef9-e053-2995a90a5149	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	QPharma, Inc.	14e7472a-24fe-4ae1-abc7-c2972ce8cd74	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
meloxicam	MELOXICAM	A-S Medication Solutions	11984306-9b71-4c2a-81bc-8942966810be	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: meloxicam generic name: MELOXICAM
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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9097	ORIG	2006-07-21