Application 213324

Type: ANDA
Sponsor: UNICHEM LABS 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	TE codes	Approval date
A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06
A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06
A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213324-001	AB
A213324-002	AB
A213324-003	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 · 111 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	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A213324-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213324-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213324-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213324-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213324-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213324-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213324-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213324-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213324-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213324-001	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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	51d85ea8-8317-4a76-a108-20383f118ad4	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	16ed7d7e-862f-db36-e063-6394a90a02a5	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	106d9730-5938-8f27-e063-6294a90adc68	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	eb2b24b1-2851-440f-9075-b6a123a1fd5c	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324 ndc (product): 70518-3251
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	348c7ad4-b380-4b78-88f4-106b94079f52	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ac8ae965-af50-41d3-8df5-ca6daf4bbd1c	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DirectRx	cdc5b438-6b6b-0cdd-e053-2a95a90a7f75	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324 ndc (product): 72189-280
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	6b06b11c-0546-4f6e-9509-ba612bbcb9fd	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324 ndc (product): 50090-5711
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	f3187074-6b55-44a3-b969-40a808eb034a	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324 ndc (product): 50090-5772
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	bf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324 ndc (product): 50090-5712
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	1cb40f47-7fbb-4537-922d-04a08dd921c5	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324 ndc (product): 50090-5713
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PHOENIX RX LLC	4383b26f-c39f-3d6a-e063-6294a90aba03	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	37056cab-953e-43ba-9b4c-163a739a52f7	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	820dca15-5b7f-41e0-955f-73f942709264	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fbd38abb-02ae-1a36-e053-6294a90abe65	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Redpharm Drug, Inc.	09d0e2fc-76a4-bb7d-e063-6394a90a4a7d	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine HCL	CYCLOBENZAPRINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	c859f63a-09de-4eec-e053-2a95a90a312f	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324 ndc (product): 80425-0155
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	e332763b-00c6-41bf-84ae-a07d9ef79697	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	f2286776-a7de-42dc-b745-d250e741eeb6	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324 ndc (product): 50090-5756
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	c68d17e2-2311-8e17-e053-2995a90a565b	2024-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324 ndc (product): 68071-2471

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-413	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-413	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-413	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-414	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-414	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-414	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-415	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-415	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-415	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
50090-5711	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5712	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5713	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5756	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5756	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5772	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	A-S Medication Solutions	ANDA	Current
53002-0523	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-925	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-925	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-925	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-925	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-925	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-925	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-926	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-926	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-926	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-926	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-926	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-926	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Quality Care Products, LLC	ANDA	Current
68071-2471	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3251	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3251	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3251	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3251	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3251	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3251	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1961	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1961	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1962	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1962	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Bryant Ranch Prepack	ANDA	Current
72189-280	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DirectRx	ANDA	Current
72189-280	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DirectRx	ANDA	Current
76420-256	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Asclemed USA, Inc.	ANDA	Current
80425-0155	Flexiril	Cyclobenzaprine 5mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0155	Flexiril	Cyclobenzaprine 5mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0155	Cyclobenzaprine HCL	Cyclobenzaprine HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0155	Cyclobenzaprine HCL	Cyclobenzaprine HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current