Application 090478

Type: ANDA
Sponsor: INVAGEN PHARMS

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 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
A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2010-07-23
A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2010-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090478-001	AB
A090478-002	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A090478-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090478-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090478-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090478-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090478-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090478-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090478-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090478-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090478-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090478-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090478-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090478-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090478-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090478-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090478-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090478-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090478-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090478-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090478-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090478-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090478-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090478-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090478-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090478-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090478-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090478-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090478-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090478-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090478-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090478-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090478-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090478-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090478-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090478-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090478-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090478-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090478-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090478-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090478-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090478-002	AB	1	`f41ea6bd6efb…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Cipla USA Inc.	575a31fb-04c5-4001-88a7-c33adbacc6a8	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478 ndc (product): 69097-846 ndc (product): 69097-845
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NuCare Pharmaceuticals, Inc.	4fbbc5b6-7aac-34e5-e054-00144ff88e88	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478 ndc (product): 68071-3154
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NuCare Pharmaceuticals, Inc.	4a2b5f25-a333-15f3-e054-00144ff8d46c	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478 ndc (product): 68071-3150
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Northwind Health Company, LLC	e04eea45-12ec-4d2b-e053-2a95a90a6b76	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478 ndc (product): 51655-973
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	American Health Packaging	269bc278-963d-4830-816a-39bb4bf8c936	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478 ndc (product): 60687-558
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	AvPAK	64f6d1be-4067-a5c7-2343-4aed651a0cac	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478 ndc (product): 50268-190
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	AvPAK	e530fd1e-06fd-0432-e053-2995a90adf5f	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478 ndc (product): 50268-191
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Aphena Pharma Solutions - Tennessee, LLC	3bc7e2b4-e1a0-66e3-e063-6294a90a676a	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	EXELAN PHARMACEUTICALS, INC.	cf81da00-7c6d-4477-bb70-b3c2abea177a	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NCS HealthCare of KY, LLC dba Vangard Labs	53688de9-2031-4d19-b422-4000285f7f47	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478 ndc (product): 0615-8084
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Proficient Rx LP	ae6de8d8-33c2-40bd-9dd3-782c879a9d8f	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478 ndc (product): 63187-812

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 1 of 2 · 90 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8084	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
12634-528	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Apotheca Inc.	ANDA	Current
31722-282	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Camber Pharmaceuticals	ANDA	Current
31722-283	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Camber Pharmaceuticals	ANDA	Current
45865-433	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Medsource Pharmaceuticals	ANDA	Current
45865-433	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Medsource Pharmaceuticals	ANDA	Current
50090-3253	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	A-S Medication Solutions	ANDA	Current
50090-3253	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	A-S Medication Solutions	ANDA	Current
50268-190	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	AvPAK	ANDA	Current
50268-190	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	AvPAK	ANDA	Current
50268-190	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	AvPAK	ANDA	Current
50268-191	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	AvPAK	ANDA	Current
50436-0846	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Unit Dose Services	ANDA	Current
51655-973	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Northwind Pharmaceuticals	ANDA	Current
53002-0521	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3080	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3080	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-311	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-459	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
58118-0846	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0846	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0846	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Clinical Solutions Wholesale, LLC	ANDA	Current
60687-558	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	American Health Packaging	ANDA	Current
60687-558	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	American Health Packaging	ANDA	Current
61919-064	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-064	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-065	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct Rx	ANDA	Current
61919-305	CYCLOBENZAPRINE	CYCLOBENZAPRINE	DIRECT RX	ANDA	Current
61919-305	CYCLOBENZAPRINE	CYCLOBENZAPRINE	DIRECT RX	ANDA	Current
61919-544	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
63187-342	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-342	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-812	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Proficient Rx LP	ANDA	Current
63187-812	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Proficient Rx LP	ANDA	Current
63187-812	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Proficient Rx LP	ANDA	Current
63187-812	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Proficient Rx LP	ANDA	Current
63187-812	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Proficient Rx LP	ANDA	Current
66267-064	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-775	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-775	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
67046-148	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Coupler Enterprises	ANDA	Current
67296-1396	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1396	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1396	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1396	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1728	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	RedPharm Drug, Inc.	ANDA	Current
67296-1728	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	RedPharm Drug, Inc.	ANDA	Current
68071-3149	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3150	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3150	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3150	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3154	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3154	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3154	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68645-517	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-518	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68788-7398	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7398	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7398	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9295	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
69097-845	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Cipla USA Inc.	ANDA	Current
69097-845	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Cipla USA Inc.	ANDA	Current
69097-845	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Cipla USA Inc.	ANDA	Current
69097-846	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Cipla USA Inc.	ANDA	Current
69097-846	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Cipla USA Inc.	ANDA	Current
69097-846	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Cipla USA Inc.	ANDA	Current
70518-0082	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0082	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0082	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0082	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0082	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0082	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0082	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0211	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0390	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0635	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0635	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0635	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0635	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0635	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current