Application 073144

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	Yes
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 43.

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	Approval date
A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30
A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03
A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073144-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2006-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073144-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2013-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073144-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	1991-05-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A073144-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A073144-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A073144-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073144-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073144-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073144-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073144-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A073144-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A073144-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073144-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A073144-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A073144-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073144-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A073144-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A073144-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073144-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A073144-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A073144-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073144-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A073144-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A073144-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073144-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A073144-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A073144-003	AB	1	`ea99ee380514…`

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 10 · 182 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	59b428fa-5013-4b2b-872f-16ba4a9d4f5d	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9161cb5e-63e5-41d7-9bde-66c7b7b7a2f3	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3aaa4808-7f2d-410c-9b6c-193549ec0845	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7829a96a-3668-4d88-90e9-0ecbedb2bd7e	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3baeda95-d098-437a-b360-87a9c3f3fd9b	2025-04-30	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
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0751	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0751	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0761	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0761	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0771	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0771	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-644	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-644	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51655-439	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride	Northwind Pharmaceuticals	ANDA	Current
55154-5571	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Cardinal Health	ANDA	Current
55154-5571	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride	Cardinal Health	ANDA	Current