Application 021777

Type: NDA
Sponsor: TEVA PHARMS INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	Yes	No
002	AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021777-001	AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01
N021777-002	AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021777-001	AB
N021777-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021777-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021777-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021777-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021777-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021777-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021777-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021777-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021777-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021777-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021777-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021777-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021777-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021777-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021777-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021777-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021777-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021777-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021777-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021777-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021777-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021777-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021777-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021777-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021777-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021777-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021777-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021777-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021777-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021777-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021777-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021777-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021777-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021777-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021777-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021777-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021777-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 382 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	7544372	2023-11-14	U-979			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	7790199	2023-11-14		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	7820203	2023-11-14		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	7829121	2023-11-14	U-1088			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	8877245	2023-11-14	U-979		2018-06-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	9375410	2023-11-14	U-1088		2016-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	9399025	2023-11-14	U-979	Drug product	2016-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	7387793	2025-02-26		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	7544372	2023-11-14	U-979			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	7790199	2023-11-14		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	7820203	2023-11-14		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	7829121	2023-11-14	U-1088			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	8877245	2023-11-14	U-979		2018-06-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	9375410	2023-11-14	U-1088		2016-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	9399025	2023-11-14	U-979	Drug product	2016-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	7387793	2025-02-26		Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021777-001	7544372	2023-11-14	U-979			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	7790199	2023-11-14		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	7820203	2023-11-14		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	7829121	2023-11-14	U-1088			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	8877245	2023-11-14	U-979		2018-06-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	9375410	2023-11-14	U-1088		2016-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	9399025	2023-11-14	U-979	Drug product	2016-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	7387793	2025-02-26		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	7544372	2023-11-14	U-979			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	7790199	2023-11-14		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	7820203	2023-11-14		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	7829121	2023-11-14	U-1088			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	8877245	2023-11-14	U-979		2018-06-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	9375410	2023-11-14	U-1088		2016-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	9399025	2023-11-14	U-979	Drug product	2016-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	7387793	2025-02-26		Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021777-001	7544372	2023-11-14	U-979			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	7790199	2023-11-14		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	7820203	2023-11-14		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	7829121	2023-11-14	U-1088			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	8877245	2023-11-14	U-979		2018-06-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	9375410	2023-11-14	U-1088		2016-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	9399025	2023-11-14	U-979	Drug product	2016-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	7387793	2025-02-26		Drug product		`4b0b4de00fa7…`

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 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	96b650d8-4ad5-42af-aa8c-aa0ac25abfb5	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	30e61110-5bc8-4134-8456-538558479735	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	3175d24d-e8a0-4f14-bed9-a60ad59ac7e7	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	8a8c9479-b3ab-453a-bd8a-deaf38000742	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Doc Rx	d4457b8c-fff8-4c19-8d5a-a667161e5446	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PHOENIX RX LLC	3a116427-c427-c3bc-e063-6294a90ac539	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	dd546a0e-e5be-4232-8ad8-fcd7d5f9a903	2025-05-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777 ndc (product): 0115-1436 ndc (product): 0115-1437
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	2169667d-4f4b-472d-929b-8a0bcbddbe9c	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777 ndc (product): 63629-8206
Cyclobenzaprine HCL ER	CYCLOBENZAPRINE HCL ER	Direct_Rx	e4a3383a-7b30-25b7-e053-2995a90a341b	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777 ndc (product): 72189-362
Cyclobenzaprine HCL ER	CYCLOBENZAPRINE HCL ER	Direct_Rx	ed0b9acc-132f-64c0-e053-2995a90a198c	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777 ndc (product): 72189-389
Cyclobenzaprine HCL ER	CYCLOBENZAPRINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	f8360da5-f1d3-1d89-e053-6294a90ad31c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	259fb05a-4f45-9c8e-e063-6294a90a4484	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	ca74d27a-f7c6-462d-a913-1cfa061bd8f3	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777 ndc (product): 0093-1921 ndc (product): 0093-1920
AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	Cephalon, LLC	3902123b-1365-ac3c-0934-afff9eeeb1bd	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777 ndc (product): 63459-701 ndc (product): 63459-700

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0115-1436	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1436	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1436	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1436	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1436	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1437	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1437	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1437	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1437	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1437	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
21695-723	AMRIX	Cyclobenzaprine Hydrochloride	Rebel Distributors Corp.	NDA	Current
21695-953	AMRIX	Cyclobenzaprine Hydrochloride	Rebel Distributors Corp	NDA	Current
35356-262	Amrix	Cyclobenzaprine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
50090-1101	AMRIX	Cyclobenzaprine Hydrochloride	A-S Medication Solutions	NDA	Current
55700-981	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Quality Care Products, LLC	NDA AUTHORIZED GENERIC	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, LLC	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, LLC	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63629-8206	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8206	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
72189-362	Cyclobenzaprine HCL ER	Cyclobenzaprine HCL ER	Direct_Rx	NDA	Current
72189-389	Cyclobenzaprine HCL ER	Cyclobenzaprine HCL ER	Direct_Rx	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78282	SUPPL	2024-04-26
78280	SUPPL	2024-04-26
58429	SUPPL	2019-04-26
58408	SUPPL	2019-04-25
37627	SUPPL	2016-06-01
28577	SUPPL	2016-05-27
37625	SUPPL	2013-06-11
16355	SUPPL	2013-06-11
6167	SUPPL	2013-06-11
6166	SUPPL	2013-06-11
37626	SUPPL	2013-04-16
6168	SUPPL	2013-04-16
21815	ORIG	2008-05-06
6165	SUPPL	2008-03-26
6164	ORIG	2007-02-12
16354	ORIG	2007-02-02