Application 078048

Type: ANDA
Sponsor: KVK TECH

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
A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2011-02-28
A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2011-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078048-001	AB
A078048-002	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	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`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	A078048-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078048-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078048-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078048-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078048-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078048-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078048-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078048-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078048-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078048-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078048-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078048-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078048-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078048-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078048-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078048-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078048-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078048-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078048-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078048-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078048-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078048-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078048-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078048-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078048-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078048-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078048-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078048-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078048-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078048-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078048-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078048-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078048-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078048-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078048-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078048-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078048-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078048-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078048-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078048-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e505c31b-4618-4e4f-8da6-92030464004f	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078048 application number: ANDA078048 ndc (product): 43063-494
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	American Health Packaging	5f321a03-ccfb-4c11-ac60-a461a5580c69	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078048 application number: ANDA078048 ndc (product): 68084-753
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	f14bc532-e30f-490f-b97b-d0dab9a2ba0c	2021-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078048 application number: ANDA078048 ndc (product): 63187-094
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	bb23383c-087a-4fb1-8917-edecd1ec4527	2020-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078048 application number: ANDA078048 ndc (product): 71610-016
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	KVK-TECH, Inc.	5b756c04-e7b8-4efe-815a-3f3e020727fb	2018-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078048 application number: ANDA078048 ndc (product): 10702-007 ndc (product): 10702-006

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 60 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8182	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8182	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-200	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10702-006	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	KVK-TECH, Inc.	ANDA	Current
10702-007	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	KVK-TECH, Inc.	ANDA	Current
43063-494	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-494	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-494	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-494	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-494	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-494	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-494	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-516	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-516	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-516	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-516	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-917	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-917	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-917	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-917	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-917	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2761	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-0006	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Unit Dose Services	ANDA	Current
50436-0006	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Unit Dose Services	ANDA	Current
52959-846	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	H. J. Harkins Company Inc.	ANDA	Current
53002-0520	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-0520	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-527	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-527	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-527	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63187-094	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-094	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-094	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-094	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
67046-117	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
67296-1343	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1343	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1343	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-1998	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68084-753	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	American Health Packaging	ANDA	Current
68084-753	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	American Health Packaging	ANDA	Current
68084-753	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	American Health Packaging	ANDA	Current
68788-9508	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0191	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0191	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0191	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0191	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0191	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0191	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0191	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-667	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-667	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70938-003	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	1 Veterans Health	ANDA	Current
70938-003	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	1 Veterans Health	ANDA	Current
71335-0128	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0128	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-016	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-016	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-016	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72789-188	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current