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 5 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	A-S Medication Solutions	eb908b77-741c-473a-b2e9-4f82167c3088	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	4923ac1f-d463-465b-9e99-7312aef87861	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	d6448bb1-9b8d-45f4-a14b-8328248e586e	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	3bddfe25-00ba-747f-e063-6394a90a9ce6	2025-08-08	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Aphena Pharma Solutions - Tennessee, LLC	3bc7e2b4-e1a0-66e3-e063-6294a90a676a	2025-08-07	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	820dca15-5b7f-41e0-955f-73f942709264	2025-08-01	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	SOLA Pharmaceuticals, LLC	db930d05-3f92-41f1-888c-301b2c4565e6	2025-07-30	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	AvKARE	a264ab9f-cc12-325f-e053-2a95a90a53d9	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	PHOENIX RX LLC	3a90171b-aef3-0691-e063-6294a90a6560	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PHOENIX RX LLC	3a116427-c427-c3bc-e063-6294a90ac539	2025-07-21	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	6536b470-9a4e-4174-85b8-479f64cc3296	2025-07-14	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	e3b5fc92-9186-6944-e053-2a95a90a1c9f	2025-07-08	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Coupler LLC	37c8c0d6-98c0-c1a5-e063-6394a90a7931	2025-06-17	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	34f4e63a-1259-0226-e063-6294a90a9fc4	2025-06-16	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	dd546a0e-e5be-4232-8ad8-fcd7d5f9a903	2025-05-27	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Redpharm Drug	0ab1b6f8-5d73-f97a-e063-6294a90a9fbf	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Fexmid	CYCLOBENZAPRINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	41838966-de0b-4855-83b8-2ff6c764ed1f	2025-04-07	Warnings, Adverse reactions	Name fallback generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	3f1b9c8a-8f75-4b84-af0c-739815937fd7	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	2169667d-4f4b-472d-929b-8a0bcbddbe9c	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	dcef9b63-f998-4852-920d-c356623cea6a	2025-03-21	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