Application 078218

Type: ANDA
Sponsor: ORIT LABS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	7.5MG	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	TE codes	Approval date
A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18
A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19
A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078218-001	AB
A078218-002	AB
A078218-003	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 · 118 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	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 118 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	A078218-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078218-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078218-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078218-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078218-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078218-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078218-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078218-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078218-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078218-001	AB	1	`8072bd15b7f6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	390151d4-5fcb-46e2-92e6-de184827f43d	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078218 application number: ANDA078218 ndc (product): 65162-541 ndc (product): 65162-540
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	31bb92f6-ec8c-4636-8b07-8814417fe78e	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078218 application number: ANDA078218 ndc (product): 53746-541 ndc (product): 53746-540
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	3cdde96c-9fc9-4698-872a-25c05318ecb5	2021-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078218 application number: ANDA078218 ndc (product): 62332-649 ndc (product): 62332-647 ndc (product): 62332-646
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	50aa421f-1d73-4b43-8528-2617ef2507dc	2019-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078218 application number: ANDA078218 ndc (product): 63187-157

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-159	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
21695-037	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Rebel Distributors	ANDA	Current
33261-033	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
33358-097	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RxChange Co.	ANDA	Current
50090-2605	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2644	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2678	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2737	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	A-S Medication Solutions	ANDA	Current
53746-540	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-540	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-540	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-540	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-541	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-541	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-541	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-541	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53808-0948	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
55289-403	Comfort Pac With Cyclobenzaprine	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-567	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
58118-0541	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Clinical Solutions Wholesale	ANDA	Current
58517-080	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	New Horizon Rx Group, LLC	ANDA	Current
62332-646	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-646	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-647	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-647	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-649	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-649	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
63187-157	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-157	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63629-1339	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1339	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7653	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7653	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7960	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
63629-7960	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
64205-541	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	ReadyMeds	ANDA	Current
65162-540	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-540	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-540	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-541	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-541	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-541	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
67296-0447	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug Inc.	ANDA	Current
69336-104	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Sterling Knight Pharmaceuticals,LLC	ANDA	Current
71335-1089	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1089	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1178	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1178	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current