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 2 of 6 · 120 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Sportpharm LLC	f210e6b4-43b3-4d33-bc0b-013a0f907d3e	2026-04-03	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	REMEDYREPACK INC.	7048d6cc-88a7-4743-8481-63a2005fa27a	2026-02-17	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
MELOXICAM	MELOXICAM	A-S Medication Solutions	cdb998b4-093f-45de-90eb-a3dc03dbfd1e	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MELOXICAM generic name: MELOXICAM
Meloxicam	MELOXICAM	Bryant Ranch Prepack	7895f389-1509-4e03-8668-526ab1627fc8	2026-02-05	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