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 7 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	Redpharm Drug	fc61c9f5-b0ec-3ff8-e053-6394a90adeb7	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Redpharm Drug	09d35c34-11fa-3a5d-e063-6294a90ab172	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DirectRx	ceb56ab8-4a76-6dee-e053-2995a90aab30	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	a58cf759-048b-6740-e053-2a95a90a8b43	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	a512d34c-8164-0c04-e053-2995a90a1942	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	01e18825-1cf9-a98c-e063-6294a90ae0a4	2025-01-14	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	3dd2bde1-f06d-493a-91c7-22b28a5e1699	2025-01-07	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	EXELAN PHARMACEUTICALS, INC.	cf81da00-7c6d-4477-bb70-b3c2abea177a	2025-01-01	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	afcad582-ab59-4f70-e053-2a95a90a04e4	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	db49801d-9bde-5dd0-e053-2a95a90aee53	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2998c9e6-2f60-ef35-e063-6394a90a7bc7	2024-12-18	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Quality Care Products LLC	794d350b-6c88-41d5-b68b-3e2c57ee2a4f	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	American Health Packaging	5f321a03-ccfb-4c11-ac60-a461a5580c69	2024-12-13	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	4c51f56b-33c3-4611-bba8-876d9dde7aff	2024-11-27	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	259fb05a-4f45-9c8e-e063-6294a90a4484	2024-10-29	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	bfdd9460-5dfa-4588-8f4f-9d227c1717d5	2024-10-24	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	390151d4-5fcb-46e2-92e6-de184827f43d	2024-10-24	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	0a695685-cfec-464e-840c-32e3b7a68bd3	2024-08-21	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	193744c8-ff8e-4f65-aec1-1c13f471ac82	2024-08-21	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	59f31ca3-1b28-4768-bb29-520f06f4a9f5	2024-08-20	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.