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 43.

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 · 43 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	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…`
2022-10-28 04:53 UTC	2022-10	A074421-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1995-09-29	`f41ea6bd6efb…`

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 1 of 10 · 182 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	5d536e88-62be-45bd-bd09-0efc53fe12b9	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Sportpharm LLC	71185d15-3fd7-42b7-83a6-8357e3aaef43	2026-09-05	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	34e57aff-dc4b-4631-9d57-31020244835d	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	37056cab-953e-43ba-9b4c-163a739a52f7	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	30e61110-5bc8-4134-8456-538558479735	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	ba659e1a-0091-45f6-b418-f4f36c9a2c79	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	3175d24d-e8a0-4f14-bed9-a60ad59ac7e7	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	903e3a5a-7c58-b70d-e053-2a95a90a6f9d	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	e4ed7ad2-cf58-4fdb-bc8c-d89f23b01210	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	53bef1ab-55c0-cc52-e063-6394a90a12b3	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
TONMYA	CYCLOBENZAPRINE HYDROCHLORIDE	Tonix Medicines, Inc.	6fa59588-ce9b-48cf-8c5f-725a448f8571	2026-08-14	Warnings, Adverse reactions	Name fallback generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Redpharm Drug	58e6d82b-52fd-cca3-e063-6294a90a1104	2026-08-13	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	b09ca979-ab6b-441b-a66f-41ca32eae6cb	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	8bef97d4-1b92-4316-8733-7751d627230f	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	eb2b24b1-2851-440f-9075-b6a123a1fd5c	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Cardinal Health 107, LLC	df902d94-9d2b-4139-aebb-3eb6b8b8cd54	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	f2eb32c3-3da0-4938-9ed9-ea8420450fde	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8c66b5ed-f773-0779-e053-2995a90ad1f1	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TruPharma LLC	08adc97f-feef-46fb-ac75-f015b4f3a43a	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4ee4feec-4590-fa7f-e063-6394a90a5550	2026-07-17	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