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 6 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	30ca08c7-4ee3-2f37-e063-6294a90ae31a	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Jubilant Cadista Pharmaceuticals Inc.	592871f6-0eb2-4624-9e10-bd8bf767c002	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	6018b6e9-938d-4fc9-86d7-1fd1d7bfcc58	2025-02-20	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	14f64ceb-ea5c-4d7c-a0c1-3f6a64847290	2025-02-20	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	aa29e260-fb77-415a-a505-3230d30c8945	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fbd38abb-02ae-1a36-e053-6294a90abe65	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	418e3974-f7dd-4f27-bee5-3c2fb0531c4c	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	05641925-7b10-4b30-b6e8-44b416a5e77e	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	96207b29-033b-46a3-961f-e5125288d50f	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Redpharm Drug, Inc.	09d0e2fc-76a4-bb7d-e063-6394a90a4a7d	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
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

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