Application 214732

Type: ANDA
Sponsor: NOVAST LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	No	No
002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	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
A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2024-08-27
A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2024-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214732-001	AB
A214732-002	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.

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	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214732-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214732-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-08-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214732-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214732-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214732-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214732-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214732-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214732-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214732-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214732-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214732-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214732-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214732-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214732-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214732-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214732-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214732-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214732-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214732-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214732-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214732-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214732-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214732-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214732-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214732-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214732-002	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214732-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214732-002	AB	1	`a50c72e98297…`

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 · 183 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.