Application 078722

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	7.5MG	No	No
003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2008-05-12
A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2008-05-12
A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-05-12

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 4 · 123 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	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2008-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL		2008-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2008-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL		2008-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A078722-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078722-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078722-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078722-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078722-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078722-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078722-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078722-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078722-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078722-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078722-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078722-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078722-001	AB	1	`5d02ea3f76ae…`

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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	ae3a3f5c-fb64-4a43-be88-a2fc7c298ac1	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722 ndc (product): 63187-590
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	a4cc7965-2ba8-42e8-8c5c-b90145a6598a	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722 ndc (product): 68788-9967
Cyclobenzaprine HCL	CYCLOBENZAPRINE HCL	PHOENIX RX LLC	3a397e88-d267-feed-e063-6294a90a7710	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	81917fa4-c79c-46e2-bfbb-507fc0d7ed1b	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722 ndc (product): 50090-1848
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	SA3, LLC	a4ae481f-9e47-470a-b4d1-5a33c0df8761	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722 ndc (product): 69420-1001
Cyclobenzaprine HCL	CYCLOBENZAPRINE HCL	Advanced Rx of Tennessee, LLC	b062cb80-79a9-c5d8-e053-2a95a90aecfc	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Quality Care Products LLC	794d350b-6c88-41d5-b68b-3e2c57ee2a4f	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722 ndc (product): 55700-239
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	59f31ca3-1b28-4768-bb29-520f06f4a9f5	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722 ndc (product): 71335-0096
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	07e3ec53-f1f2-4231-aec6-1772a146ba88	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722 ndc (product): 76420-010

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 84 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-859	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Aidarex Pharmaceuticals LLC	ANDA	Current
42254-239	CYCLOBENZAPRINE HYROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Rebel Distributors Corp	ANDA	Current
45865-685	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Medsource Pharmaceuticals	ANDA	Current
50090-1848	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1848	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-1101	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Unit Dose Services	ANDA	Current
53149-4841	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	All Pharma, LLC	ANDA	Current
53149-4852	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	All Pharma, LLC	ANDA	Current
53217-170	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
55700-239	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-239	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-239	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-239	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-762	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-762	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Quality Care Products, LLC	ANDA	Current
61919-025	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-261	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-261	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-261	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-261	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-261	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-414	CYCLOBENZPRINE HCL	CYCLOBENZPRINE HCL	DIRECTRX	ANDA	Current
61919-414	CYCLOBENZPRINE HCL	CYCLOBENZPRINE HCL	DIRECTRX	ANDA	Current
61919-681	CYCLOBENZAPRINE HCI	CYCLOBENZAPRINE HCI	DIRECTRX	ANDA	Current
61919-681	CYCLOBENZAPRINE HCI	CYCLOBENZAPRINE HCI	DIRECTRX	ANDA	Current
61919-681	CYCLOBENZAPRINE HCI	CYCLOBENZAPRINE HCI	DIRECTRX	ANDA	Current
61919-681	CYCLOBENZAPRINE HCI	CYCLOBENZAPRINE HCI	DIRECTRX	ANDA	Current
61919-681	CYCLOBENZAPRINE HCI	CYCLOBENZAPRINE HCI	DIRECTRX	ANDA	Current
61919-681	CYCLOBENZAPRINE HCI	CYCLOBENZAPRINE HCI	DIRECTRX	ANDA	Current
63187-123	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
63187-590	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-590	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-590	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-923	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-923	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63304-214	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Ranbaxy Pharmaceuticals Inc	ANDA	Current
63304-215	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Ranbaxy Pharmaceuticals Inc	ANDA	Current
63304-216	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Ranbaxy Pharmaceuticals Inc	ANDA	Current
63629-4664	CYCLOBENZAPRINE HYROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
68071-1961	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1961	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1961	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68258-7150	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Dispensing Solutions, Inc.	ANDA	Current
68788-9967	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9967	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9967	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9967	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9967	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
69306-075	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Doc Rx	ANDA	Current
69306-075	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Doc Rx	ANDA	Current
69306-075	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Doc Rx	ANDA	Current
69420-1001	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	SA3, LLC	ANDA	Current
69420-1001	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	SA3, LLC	ANDA	Current
69420-1001	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	SA3, LLC	ANDA	Current
69420-1001	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	SA3, LLC	ANDA	Current
69420-1001	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	SA3, LLC	ANDA	Current
71085-010	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	IPG PHARMACEUTICALS, INC.	ANDA	Current
71205-132	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-132	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-132	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0096	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0096	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0096	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0096	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71800-003	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Innovida Pharmaceutique Corporation	ANDA	Current
71800-003	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Innovida Pharmaceutique Corporation	ANDA	Current
71800-003	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Innovida Pharmaceutique Corporation	ANDA	Current
73086-1001	NOpiod-TC	Cyclobenzaprine Hydrochloride, Lidocaine, Menthol	Skya Health, LLC	ANDA	Current
73086-1001	NOpiod-TC	Cyclobenzaprine Hydrochloride, Lidocaine, Menthol	Skya Health, LLC	ANDA	Current
73086-901	NOpioid-TC	Cyclobenzaprine Hydrochloride, Lidocaine, Menthol	Skya Health, LLC	ANDA	Current
73086-905	NOpioid-LMC	Cyclobenzaprine Hydrochloride, Lidocaine, Menthol	Skya Health, LLC	ANDA	Current
73086-906	NOpioid-LMC	Cyclobenzaprine Hydrochloride, Lidocaine and Menthol	Skya Health, LLC	ANDA	Current
76420-010	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Asclemed USA, Inc.	ANDA	Current
76420-010	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Asclemed USA, Inc.	ANDA	Current
76420-010	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Asclemed USA, Inc.	ANDA	Current
76420-019	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Asclemed USA, Inc.	ANDA	Current
76519-1000	CYCLOBENZAPRINE HYROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	H.J. Harkins Company, Inc.	ANDA	Current
80425-0015	Flexeril	Cyclobenzaprine Hydrochloride	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current
80425-0015	Cyclobenzaprine HCL	Cyclobenzaprine HCL	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current
80425-0015	Cyclobenzaprine HCL	Cyclobenzaprine HCL	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current