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 9 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	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
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	d8112916-28ae-452c-8ec8-a4972e5f549b	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	ffd82a69-a64c-4399-8f5d-bddc70cdc3cf	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Proficient Rx LP	ae6de8d8-33c2-40bd-9dd3-782c879a9d8f	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	3cdde96c-9fc9-4698-872a-25c05318ecb5	2021-11-19	Warnings, Adverse reactions	Name fallback brand name: CYCLOBENZAPRINE HYDROCHLORIDE generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Aurobindo Pharma Limited	1154688c-1383-442b-a3a5-ec01e038795c	2021-11-09	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	f14bc532-e30f-490f-b97b-d0dab9a2ba0c	2021-10-01	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	0280b504-4a42-44f3-8a1a-34a20eac054a	2021-05-26	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	bb23383c-087a-4fb1-8917-edecd1ec4527	2020-06-03	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	be5201bc-e1f1-41af-be46-4a8fbb223b86	2020-05-27	Warnings, Adverse reactions	Name fallback brand name: Cyclobenzaprine Hydrochloride generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	50aa421f-1d73-4b43-8528-2617ef2507dc	2019-12-01	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.

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