Application 077927

Type: ANDA
Sponsor: UNICHEM

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
A077927-001	MELOXICAM	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-12-20
A077927-002	MELOXICAM	MELOXICAM	15MG	TABLET / ORAL	AB		2006-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077927-001	AB
A077927-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-12-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077927-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077927-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077927-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077927-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077927-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077927-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077927-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077927-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077927-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077927-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077927-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077927-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077927-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077927-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077927-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077927-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077927-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077927-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077927-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077927-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077927-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077927-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077927-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077927-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077927-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077927-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077927-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077927-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077927-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077927-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077927-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077927-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077927-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077927-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077927-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077927-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077927-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077927-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077927-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077927-002	AB	1	`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 1 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
meloxicam	MELOXICAM	Sportpharm LLC	f210e6b4-43b3-4d33-bc0b-013a0f907d3e	2026-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	Coupler LLC	56440abd-80f4-7b8d-e063-6394a90a2a91	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	HAWAII REPACK, INC.	68b50c82-7130-428a-884c-98576887e99a	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	REMEDYREPACK INC.	5d153147-f1c8-4624-8028-fe84680d7143	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	REMEDYREPACK INC.	3e8a6283-1e1b-4199-ac73-f42255c7e907	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	REMEDYREPACK INC.	ffaf1db4-25a9-48d1-a624-242f9d8e14c7	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	St. Mary's Medical Park Pharmacy	60c954d5-bd5a-33f9-e053-2a91aa0ab597	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	St. Mary's Medical Park Pharmacy	60c9ab35-4b6e-383d-e053-2a91aa0a26ad	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	Proficient Rx LP	459bd9c0-1102-46d3-8020-5fec80d1ec36	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	PD-Rx Pharmaceuticals, Inc.	1d8b617a-b9b3-473c-be9b-f34a585a1b3b	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
MELOXICAM	MELOXICAM	Direct Rx	c172a767-eb26-4995-b2a2-f3c5e87b4943	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	af9ce58c-3cd7-769f-e053-2a95a90a5385	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927 ndc (product): 80425-0041
meloxicam	MELOXICAM	Preferred Pharmaceuticals Inc.	c6f37980-8e09-4f2e-a768-b3d22cbe3d49	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	Northwind Health Company, LLC	3ce43f4a-c525-4ce1-b328-514b3912e305	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	Northwind Health Company, LLC	820f143f-4b0c-4466-be9a-212dab9d984b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	PHOENIX RX LLC	438311de-78e7-8bd9-e063-6394a90a7932	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	QPharma, Inc.	20ec4646-9d1c-41c9-93f6-754b3a4f234f	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	A-S Medication Solutions	67974608-326e-4e62-8430-6fbc14d1d69b	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	QPharma, Inc.	14e7472a-24fe-4ae1-abc7-c2972ce8cd74	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	A-S Medication Solutions	11984306-9b71-4c2a-81bc-8942966810be	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 3 of 3 · 198 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71335-0406	meloxicam	meloxicam	Bryant Ranch Prepack	ANDA	Current
71335-0406	meloxicam	meloxicam	Bryant Ranch Prepack	ANDA	Current
71335-0406	meloxicam	meloxicam	Bryant Ranch Prepack	ANDA	Current
71335-0406	meloxicam	meloxicam	Bryant Ranch Prepack	ANDA	Current
71335-0406	meloxicam	meloxicam	Bryant Ranch Prepack	ANDA	Current
71335-1618	meloxicam	meloxicam	Bryant Ranch Prepack	ANDA	Current
71335-1618	meloxicam	meloxicam	Bryant Ranch Prepack	ANDA	Current
71610-189	meloxicam	meloxicam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-190	meloxicam	meloxicam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-544	Meloxicam	Meloxicam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-544	Meloxicam	Meloxicam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-583	Meloxicam	Meloxicam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-583	Meloxicam	Meloxicam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72865-137	Meloxicam	Meloxicam	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-137	Meloxicam	Meloxicam	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-137	Meloxicam	Meloxicam	XLCare Pharmaceuticals Inc.	ANDA	Current
72865-138	Meloxicam	Meloxicam	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-138	Meloxicam	Meloxicam	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-138	Meloxicam	Meloxicam	XLCare Pharmaceuticals Inc.	ANDA	Current
75921-125	Meloxicam	Meloxicam	Life Line Home Care Services, Inc.	ANDA	Current
76282-152	Meloxicam	Meloxicam	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-153	Meloxicam	Meloxicam	Exelan Pharmaceuticals Inc.	ANDA	Current
76420-039	meloxicam	meloxicam	Asclemed USA, Inc.	ANDA	Current
76420-039	meloxicam	meloxicam	Asclemed USA, Inc.	ANDA	Current
76420-043	meloxicam	meloxicam	Asclemed USA, Inc.	ANDA	Current
76420-043	meloxicam	meloxicam	Asclemed USA, Inc.	ANDA	Current
80175-0124	Meloxicam	Meloxicam	Central Packaging	ANDA	Current
80175-0124	Meloxicam	Meloxicam	Central Packaging	ANDA	Current
80175-0124	Meloxicam	Meloxicam	Central Packaging	ANDA	Current
80425-0041	Mobic	Meloxicam 7.5mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0041	Meloxicam	Meloxicam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0041	Meloxicam	Meloxicam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0041	Meloxicam	Meloxicam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0044	Mobic	Meloxicam 15mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0044	Mobic	Meloxicam 15mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0044	Meloxicam	Meloxicam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0044	Meloxicam	Meloxicam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0044	Meloxicam	Meloxicam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current