Application 090228

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	TABLET;ORAL	10MG;12.5MG	No	No
002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	TABLET;ORAL	20MG;12.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09
A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2009-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090228-001	AB
A090228-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090228-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090228-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090228-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090228-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090228-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090228-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090228-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090228-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090228-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090228-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090228-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090228-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090228-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090228-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090228-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090228-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090228-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090228-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090228-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090228-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090228-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090228-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090228-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090228-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090228-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090228-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090228-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090228-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090228-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090228-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090228-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090228-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090228-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090228-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090228-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090228-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090228-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090228-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090228-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090228-002	AB	1	`74a2ff9319b5…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosinopril Sodium and Hydrochlorothiazide	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	CIPLA USA INC.	4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	2020-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090228 application number: ANDA090228 ndc (product): 69097-972 ndc (product): 69097-973

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-554	Fosinopril Sodium and Hydrochlorothiazide	Fosinopril Sodium and Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-554	Fosinopril Sodium and Hydrochlorothiazide	Fosinopril Sodium and Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-554	Fosinopril Sodium and Hydrochlorothiazide	Fosinopril Sodium and Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-555	Fosinopril Sodium and Hydrochlorothiazide	Fosinopril Sodium and Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-555	Fosinopril Sodium and Hydrochlorothiazide	Fosinopril Sodium and Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-555	Fosinopril Sodium and Hydrochlorothiazide	Fosinopril Sodium and Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
69097-972	Fosinopril Sodium and Hydrochlorothiazide	Fosinopril Sodium and Hydrochlorothiazide	CIPLA USA INC.	ANDA	Current
69097-972	Fosinopril Sodium and Hydrochlorothiazide	Fosinopril Sodium and Hydrochlorothiazide	CIPLA USA INC.	ANDA	Current
69097-973	Fosinopril Sodium and Hydrochlorothiazide	Fosinopril Sodium and Hydrochlorothiazide	CIPLA USA INC.	ANDA	Current
69097-973	Fosinopril Sodium and Hydrochlorothiazide	Fosinopril Sodium and Hydrochlorothiazide	CIPLA USA INC.	ANDA	Current