Application 077921

Type: ANDA
Sponsor: ZYDUS PHARMS USA

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
A077921-001	MELOXICAM	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19
A077921-002	MELOXICAM	MELOXICAM	15MG	TABLET / ORAL	AB	RS	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
A077921-001	AB
A077921-002	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB	RS	2006-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB		2006-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB		2006-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB		2006-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB		2006-07-19	`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	A077921-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077921-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077921-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077921-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077921-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077921-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077921-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077921-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077921-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077921-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077921-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077921-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077921-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077921-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077921-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077921-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077921-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077921-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077921-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077921-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077921-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077921-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077921-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077921-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077921-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077921-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077921-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077921-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077921-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077921-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077921-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077921-002	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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
meloxicam	MELOXICAM	Redpharm Drug	58d34e5d-4efb-3d76-e063-6394a90aa0f6	2026-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	REMEDYREPACK INC.	7048d6cc-88a7-4743-8481-63a2005fa27a	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	St. Mary's Medical Park Pharmacy	b710b959-a64d-a631-e053-2995a90a2177	2026-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Preferred Pharmaceuticals, Inc.	66bc3f93-a73b-476c-83d4-7354d2e18575	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Preferred Pharmaceuticals Inc.	e0deb1f7-b575-463f-a3f8-304cc1936075	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Coupler LLC	52bd9bcd-4902-f9dd-e063-6294a90a604e	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	REMEDYREPACK INC.	fabd063a-d3a5-44a3-90a2-e33d721b7a95	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Coupler LLC	5071e1fd-5321-42cf-e063-6294a90a0ef6	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	NuCare Pharmaceuticals,Inc.	87ef5a9b-2dd1-2ef9-e053-2995a90a5149	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
Meloxicam	MELOXICAM	American Health Packaging	937ea2ca-6b8c-4c80-9926-f4de7c8f5643	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	PHOENIX RX LLC	3ede6724-d9be-5b44-e063-6294a90afbaa	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	A-S Medication Solutions	29974b41-68b4-42cf-8835-18ae480c2952	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	af9cf496-d505-f2ba-e053-2995a90a76cf	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921 ndc (product): 80425-0042
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	af9cde70-6c74-f6a8-e053-2995a90addaf	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921 ndc (product): 80425-0045
meloxicam	MELOXICAM	A-S Medication Solutions	7df126c1-a729-4bfe-9d08-ad359c9ee3bc	2024-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Zydus Lifesciences Limited	5eb2e439-2ef2-496c-9aec-042029ae1305	2024-11-30		Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Bryant Ranch Prepack	37c030e7-f4f0-4923-847e-85325265960a	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Bryant Ranch Prepack	c51a641b-5715-4be9-baac-7fd4ec729570	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Quallent Pharmaceuticals Health LLC	2875c30d-508a-46e1-ae5a-bc7057e7cbee	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Zydus Pharmaceuticals USA Inc.	6c015f72-5ce3-4f56-8237-776fc2165b0c	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921

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 2 of 2 · 85 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
80425-0042	Meloxicam	Meloxicam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0042	Meloxicam	Meloxicam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0045	Mobic	Meloxicam 15mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0045	Meloxicam	Meloxicam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0045	Meloxicam	Meloxicam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31301	ORIG	2009-05-18