Application 074421

Type: ANDA
Sponsor: PLIVA

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL			1995-09-29

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 2 · 44 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
2026-10-15 13:18:30	2026-09	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1995-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1995-09-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1995-09-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1995-09-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1995-09-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1995-09-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1995-09-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1995-09-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074421-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074421-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074421-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074421-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074421-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074421-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074421-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074421-001	AB	1	`ea99ee380514…`

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 4 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	f32bceda-1d24-322d-e053-2995a90aae1b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	f708cf0f-8373-14a2-e053-6394a90ab3fe	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	1912d134-a909-5511-e063-6294a90aea29	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	1af467cb-7b21-4084-bb54-4634e928b167	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	15c0c7aa-8c54-4040-a1bf-2a7b421ad33f	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	81917fa4-c79c-46e2-bfbb-507fc0d7ed1b	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	43ce2c79-ec4a-5120-e063-6394a90af6e1	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	QPharma Inc	fbe6ba88-0581-50ef-e053-6394a90ab086	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	6b06b11c-0546-4f6e-9509-ba612bbcb9fd	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	f3187074-6b55-44a3-b969-40a808eb034a	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	bf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	1cb40f47-7fbb-4537-922d-04a08dd921c5	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	American Health Packaging	269bc278-963d-4830-816a-39bb4bf8c936	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PHOENIX RX LLC	4383b26f-c39f-3d6a-e063-6294a90aba03	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Doc Rx	4c054230-1978-44d2-9467-ed1994619113	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	AvPAK	64f6d1be-4067-a5c7-2343-4aed651a0cac	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	AvPAK	e530fd1e-06fd-0432-e053-2995a90adf5f	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e505c31b-4618-4e4f-8da6-92030464004f	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	8a8c9479-b3ab-453a-bd8a-deaf38000742	2025-09-24	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	cc93038f-1202-47f3-a959-2877877cc869	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE

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 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66116-527	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	MedVantx, Inc.	ANDA	Current
67296-0106	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	RedPharm Drug Inc.	ANDA	Current