Application 077797

Type: ANDA
Sponsor: PRINSTON INC

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	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2007-02-28
A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2007-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077797-001	AB
A077797-002	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	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`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	A077797-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077797-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077797-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077797-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077797-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077797-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077797-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077797-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077797-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077797-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077797-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077797-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077797-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077797-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077797-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077797-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077797-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077797-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077797-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077797-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077797-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077797-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077797-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077797-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077797-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077797-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077797-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077797-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077797-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077797-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077797-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077797-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077797-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077797-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077797-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077797-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077797-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077797-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077797-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077797-002	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 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	15c0c7aa-8c54-4040-a1bf-2a7b421ad33f	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797 ndc (product): 60429-876
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	59b428fa-5013-4b2b-872f-16ba4a9d4f5d	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9161cb5e-63e5-41d7-9bde-66c7b7b7a2f3	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3aaa4808-7f2d-410c-9b6c-193549ec0845	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7829a96a-3668-4d88-90e9-0ecbedb2bd7e	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3baeda95-d098-437a-b360-87a9c3f3fd9b	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	aa29e260-fb77-415a-a505-3230d30c8945	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797 ndc (product): 63629-1210
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	afcad582-ab59-4f70-e053-2a95a90a04e4	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	4c51f56b-33c3-4611-bba8-876d9dde7aff	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797 ndc (product): 63629-1211
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	90c7a982-6442-4241-a60b-b5dfab2abb71	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	c86303a0-7c8b-415e-acac-1070b7d0d445	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797 ndc (product): 63629-9297
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	68db3c3b-8da1-4852-90b0-3172f842aa02	2023-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Solco Healthcare U.S., LLC	f558863b-ea3f-4e4b-85e9-edb2573e7151	2022-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797 ndc (product): 43547-400 ndc (product): 43547-399
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	be5201bc-e1f1-41af-be46-4a8fbb223b86	2020-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	571fbb2b-24e0-4de3-8cfa-c267fc397b6c	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 139 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-3520	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7528	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
33261-377	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
43547-399	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Solco Healthcare U.S., LLC	ANDA	Current
43547-399	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Solco Healthcare U.S., LLC	ANDA	Current
43547-400	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Solco Healthcare U.S., LLC	ANDA	Current
43547-400	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Solco Healthcare U.S., LLC	ANDA	Current
45865-801	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	medsource pharmaceuticals	ANDA	Current
50090-0375	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0377	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0378	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0969	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4420	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4946	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4946	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5256	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5256	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50436-0400	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Unit Dose Services	ANDA	Current
51655-442	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Pharmaceuticals, LLC	ANDA	Current
52959-042	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	H. J Harkins Company Inc	ANDA	Current
55154-8143	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Cardinal Health	ANDA	Current
55700-229	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-599	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-599	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-599	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-599	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-599	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-696	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Quality Care Products, LL	ANDA	Current
55700-696	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-696	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-696	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-696	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
60429-876	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-876	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Golden State Medical Supply	ANDA	Current
60760-399	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-417	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-418	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-537	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-901	CYCLOBENZAPRINE HCL	Prilosec 40mg Tabs	DIRECTRX	ANDA	Current
61919-901	CYCLOBENZAPRINE HCL	Prilosec 40mg Tabs	Direct_Rx	ANDA	Current
61919-901	CYCLOBENZAPRINE HCL	Prilosec 40mg Tabs	Direct_Rx	ANDA	Current
61919-901	CYCLOBENZAPRINE HCL	Prilosec 40mg Tabs	Direct_Rx	ANDA	Current
61919-901	CYCLOBENZAPRINE HCL	CYCLOBENZAPRINE HCL	DIRECTRX	ANDA	Current
61919-901	CYCLOBENZAPRINE HCL	CYCLOBENZAPRINE HCL	Direct_Rx	ANDA	Current
61919-901	CYCLOBENZAPRINE HCL	CYCLOBENZAPRINE HCL	Direct_Rx	ANDA	Current
63629-1209	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1209	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1210	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1210	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1211	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1211	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1212	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1212	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1213	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1213	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8983	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9297	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63739-531	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	McKesson Corporation	ANDA	Current
63739-531	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-531	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
67046-142	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
67296-0053	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug Inc.	ANDA	Current
67296-1208	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1208	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1524	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1524	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1524	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current