Application 078407

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	CAPSULE;ORAL	EQ 20MG BASE	No	No
002	FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	CAPSULE;ORAL	EQ 40MG BASE	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
A078407-001	FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB		2012-06-12
A078407-002	FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB		2012-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078407-001	AB
A078407-002	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	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`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	A078407-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078407-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078407-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078407-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078407-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078407-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078407-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078407-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078407-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078407-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078407-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078407-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078407-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078407-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078407-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078407-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078407-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078407-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078407-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078407-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078407-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078407-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078407-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078407-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078407-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078407-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078407-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078407-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078407-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078407-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078407-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078407-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078407-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078407-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078407-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078407-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078407-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078407-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078407-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078407-002	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvastatin	FLUVASTATIN	Bryant Ranch Prepack	ccd6bbe1-e293-4e1c-9ec4-e6c217612e77	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407
Fluvastatin	FLUVASTATIN	Bryant Ranch Prepack	02db192f-0cdb-4aef-aa6e-cfb9b6cb0101	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407
Fluvastatin	FLUVASTATIN	Bryant Ranch Prepack	48801d7c-99ac-4a78-b714-299e2a5562ea	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407
Fluvastatin	FLUVASTATIN	Teva Pharmaceuticals USA, Inc.	aad8b373-0aec-4efb-8e61-3d8114b31127	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407 ndc (product): 0093-7443 ndc (product): 0093-7442
Fluvastatin	FLUVASTATIN	Bryant Ranch Prepack	e3c9f49c-051c-451a-8749-1a7bee820078	2024-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407 ndc (product): 63629-8737
Fluvastatin	FLUVASTATIN	Bryant Ranch Prepack	f5e8d1da-8911-42db-9f90-cba04b28d011	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407 ndc (product): 63629-8812

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7442	Fluvastatin	Fluvastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7442	Fluvastatin	Fluvastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7442	Fluvastatin	Fluvastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7442	Fluvastatin	Fluvastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7442	Fluvastatin	Fluvastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7443	Fluvastatin	Fluvastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7443	Fluvastatin	Fluvastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7443	Fluvastatin	Fluvastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7443	Fluvastatin	Fluvastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7443	Fluvastatin	Fluvastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
63629-8737	Fluvastatin	Fluvastatin	Bryant Ranch Prepack	ANDA	Current
63629-8737	Fluvastatin	Fluvastatin	Bryant Ranch Prepack	ANDA	Current
63629-8812	Fluvastatin	Fluvastatin	Bryant Ranch Prepack	ANDA	Current
63629-8812	Fluvastatin	Fluvastatin	Bryant Ranch Prepack	ANDA	Current