Application 072854

Type: ANDA
Sponsor: UPSHER SMITH LABS

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
002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	7.5MG	No	No

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

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
A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1991-11-19
A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03
A072854-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2026-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072854-001	AB
A072854-002	AB
A072854-003	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 · 92 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	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1991-11-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A072854-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2026-05-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072854-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2026-05-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072854-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2026-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072854-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2006-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072854-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		1991-11-19	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A072854-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A072854-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A072854-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A072854-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072854-003	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A072854-003	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 9 · 172 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NCS HealthCare of KY, LLC dba Vangard Labs	53688de9-2031-4d19-b422-4000285f7f47	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1ac77323-7526-a129-e063-6394a90a641b	2024-07-22	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8bdc725e-22e3-0f32-e053-2a95a90ae8a9	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	e332763b-00c6-41bf-84ae-a07d9ef79697	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	ca74d27a-f7c6-462d-a913-1cfa061bd8f3	2024-05-31	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	d64ca498-81c6-4e10-ba82-3a50ee47bcfc	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	07e3ec53-f1f2-4231-aec6-1772a146ba88	2024-05-07	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	Cephalon, LLC	3902123b-1365-ac3c-0934-afff9eeeb1bd	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	00dbe051-a392-e2c6-e063-6394a90ab7f3	2024-03-27	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0f8ba2c0-38e7-a536-e063-6294a90ace8d	2024-03-26	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53959	ORIG	2018-05-01