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 8 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	NuCare Pharmaceuticals,Inc.	c68d17e2-2311-8e17-e053-2995a90a565b	2024-03-11	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Medsource Pharmaceuticals	12645f19-fffc-8b08-e063-6394a90a5c55	2024-02-27	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	90c7a982-6442-4241-a60b-b5dfab2abb71	2024-01-31	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	c86303a0-7c8b-415e-acac-1070b7d0d445	2024-01-15	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	34ff8a08-0177-451f-9dbc-e21582346196	2024-01-01	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	31bb92f6-ec8c-4636-8b07-8814417fe78e	2023-12-31	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	4a2d3cae-5c64-4986-9707-cc213b70b7ad	2023-10-19	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	85128989-bfa3-4b82-94c1-f90b14ccd2f9	2023-10-18	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	74af1727-e84f-4dad-82be-045e7d23beaf	2023-09-06	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	88bdee56-d6d9-4f14-be77-1e6898ba36f5	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	6ebaccfc-f57c-4547-ade0-6a6e204f5ea0	2023-03-27	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	68db3c3b-8da1-4852-90b0-3172f842aa02	2023-03-02	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	b524d150-0a83-42d1-a884-b930e49760cd	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	1adcdd8a-30f9-4a7b-853c-948a5589acab	2023-01-03	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	2a6b2ad9-307a-4976-98b7-1b96e0408da7	2022-09-14	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	f8dec4e2-3151-4a79-b194-a11a57ada0b6	2022-09-03	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Solco Healthcare U.S., LLC	f558863b-ea3f-4e4b-85e9-edb2573e7151	2022-08-22	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	751f0d33-ceff-40b0-9329-9125f176e06a	2022-07-29	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	59945ea1-8136-4014-acd9-cdfe6e11e8da	2022-07-19	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	e3998083-e3db-4052-9b5b-19d7aaa4e658	2022-07-01	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