Application 091426

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	25MG	No	No
002	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	50MG	No	No
003	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A091426-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02
A091426-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02
A091426-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091426-001	AB
A091426-002	AB
A091426-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091426-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091426-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091426-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091426-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091426-001	AB	1	`1e350fbaab3a…`

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
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	31aeab13-8f71-49f1-b101-8b0abb21b0dc	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426 ndc (product): 71335-0966
Spironolactone	SPIRONOLACTONE	QPharma, Inc	eb314e91-6dd5-4bdb-af35-5d147b20339c	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426 ndc (product): 42708-126
Spironolactone	SPIRONOLACTONE	Amneal Pharmaceuticals of New York LLC	951b8948-dc0f-4aef-9910-82c252de936d	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426 ndc (product): 53746-511 ndc (product): 53746-515 ndc (product): 53746-514
Spironolactone	SPIRONOLACTONE	PharmPak, Inc.	c450e66a-0f05-445e-b1df-df2b17a2f064	2022-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426 ndc (product): 54348-340
Spironolactone	SPIRONOLACTONE	Amneal Pharmaceuticals LLC	fb66327e-8261-46ae-b39a-4fa79d520844	2020-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426 ndc (product): 65162-514 ndc (product): 65162-515 ndc (product): 65162-511
Spironolactone	SPIRONOLACTONE	Aphena Pharma Solutions - Tennessee, LLC	bf58378f-8304-4799-b0c0-fad8697149ab	2018-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426 ndc (product): 71610-102

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 69 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-499	Spironolactone	Spironolactone	Blenheim Pharmacal, Inc.	ANDA	Current
10544-523	Spironolactone	Spironolactone	Blenheim Pharmacal, Inc.	ANDA	Current
42708-126	Spironolactone	Spironolactone	QPharma Inc	ANDA	Current
42708-126	Spironolactone	Spironolactone	QPharma Inc	ANDA	Current
42708-126	Spironolactone	Spironolactone	QPharma Inc	ANDA	Current
50090-1292	Spironolactone	Spironolactone	A-S Medication Solutions	ANDA	Current
50090-1292	Spironolactone	Spironolactone	A-S Medication Solutions	ANDA	Current
50090-1292	Spironolactone	Spironolactone	A-S Medication Solutions	ANDA	Current
50090-1308	Spironolactone	Spironolactone	A-S Medication Solutions	ANDA	Current
50090-1308	Spironolactone	Spironolactone	A-S Medication Solutions	ANDA	Current
50090-1950	Spironolactone	Spironolactone	A-S Medication Solutions	ANDA	Current
53002-1707	Spironolactone	Spironolactone	RPK Pharmaceuticals, Inc.	ANDA	Current
53746-511	Spironolactone	Spironolactone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-511	Spironolactone	Spironolactone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-511	Spironolactone	Spironolactone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-514	Spironolactone	Spironolactone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-514	Spironolactone	Spironolactone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-514	Spironolactone	Spironolactone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-515	Spironolactone	Spironolactone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-515	Spironolactone	Spironolactone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-515	Spironolactone	Spironolactone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53808-0979	Spironolactone	Spironolactone	State of Florida DOH Central Pharmacy	ANDA	Current
54348-340	Spironolactone	SPIRONOLACTONE	PharmPak, Inc.	ANDA	Current
54348-340	Spironolactone	SPIRONOLACTONE	PharmPak, Inc.	ANDA	Current
55154-1495	Spironolactone	Spironolactone	Cardinal Health 107, LLC	ANDA	Current
55154-1495	Spironolactone	Spironolactone	Cardinal Health	ANDA	Current
55154-1495	Spironolactone	Spironolactone	Cardinal Health	ANDA	Current
55154-1495	Spironolactone	Spironolactone	Cardinal Health	ANDA	Current
55154-1495	Spironolactone	Spironolactone	Cardinal Health	ANDA	Current
55154-1495	Spironolactone	Spironolactone	Cardinal Health	ANDA	Current
55700-702	Spironolactone	Spironolactone	Quality Care Products, LL	ANDA	Current
55700-702	Spironolactone	Spironolactone	Quality Care Products, LLC	ANDA	Current
63739-544	Spironolactone	Spironolactone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-544	Spironolactone	Spironolactone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-544	Spironolactone	Spironolactone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-544	Spironolactone	Spironolactone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-544	Spironolactone	Spironolactone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-545	Spironolactone	Spironolactone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-545	Spironolactone	Spironolactone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-545	Spironolactone	Spironolactone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-545	Spironolactone	Spironolactone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-545	Spironolactone	Spironolactone	McKesson Corporation dba SKY Packaging	ANDA	Current
65162-511	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-511	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-511	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-511	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-514	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-514	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-514	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-514	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-515	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-515	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-515	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-515	Spironolactone	Spironolactone	Amneal Pharmaceuticals LLC	ANDA	Current
67046-717	Spironolactone	Spironolactone	Contract Pharmacy Services-PA	ANDA	Current
67296-1100	Spironolactone	Spironolactone	RedPharm Drug, Inc.	ANDA	Current
67296-1100	Spironolactone	Spironolactone	RedPharm Drug, Inc.	ANDA	Current
68788-7258	Spironolactone	Spironolactone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7258	Spironolactone	Spironolactone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7258	Spironolactone	Spironolactone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9729	Spironolactone	Spironolactone	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0455	Spironolactone	Spironolactone	REMEDYREPACK INC.	ANDA	Current
70518-0455	Spironolactone	Spironolactone	REMEDYREPACK INC.	ANDA	Current
70518-0455	Spironolactone	Spironolactone	REMEDYREPACK INC.	ANDA	Current
70518-0455	Spironolactone	Spironolactone	REMEDYREPACK INC.	ANDA	Current
71335-0966	Spironolactone	Spironolactone	Bryant Ranch Prepack	ANDA	Current
71335-0966	Spironolactone	Spironolactone	Bryant Ranch Prepack	ANDA	Current
71335-0966	Spironolactone	Spironolactone	Bryant Ranch Prepack	ANDA	Current
71610-102	Spironolactone	Spironolactone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current