Application 090478

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

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
A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2010-07-23
A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2010-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090478-001	AB
A090478-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`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	A090478-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090478-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090478-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090478-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090478-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090478-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090478-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090478-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090478-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090478-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090478-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090478-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090478-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090478-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090478-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090478-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090478-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090478-002	AB	1	`782e0a99824c…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Cipla USA Inc.	575a31fb-04c5-4001-88a7-c33adbacc6a8	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NuCare Pharmaceuticals, Inc.	4fbbc5b6-7aac-34e5-e054-00144ff88e88	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NuCare Pharmaceuticals, Inc.	4a2b5f25-a333-15f3-e054-00144ff8d46c	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Northwind Health Company, LLC	e04eea45-12ec-4d2b-e053-2a95a90a6b76	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	American Health Packaging	269bc278-963d-4830-816a-39bb4bf8c936	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	AvPAK	64f6d1be-4067-a5c7-2343-4aed651a0cac	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	AvPAK	e530fd1e-06fd-0432-e053-2995a90adf5f	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Aphena Pharma Solutions - Tennessee, LLC	3bc7e2b4-e1a0-66e3-e063-6294a90a676a	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	EXELAN PHARMACEUTICALS, INC.	cf81da00-7c6d-4477-bb70-b3c2abea177a	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NCS HealthCare of KY, LLC dba Vangard Labs	53688de9-2031-4d19-b422-4000285f7f47	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Proficient Rx LP	ae6de8d8-33c2-40bd-9dd3-782c879a9d8f	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 90 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-0635	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0635	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-0635	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-3159	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70518-3159	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	REMEDYREPACK INC.	ANDA	Current
70934-005	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Denton Pharma, Inc. DBA N	ANDA	Current
70934-005	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-005	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-005	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71550-101	Cyclobenzaprine Hydrochloride	Cyclobenzaprine	Virtue Rx, LLC	ANDA	Current