Application 040353

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

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

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

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	Approval date
A040353-001	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29
A040353-002	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29
A040353-003	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`8072bd15b7f6…`

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 7 · 130 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	8b76a904-6c99-485a-a05f-13a36c5f720c	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Sun Pharmaceutical Industries, Inc.	c23b6b9b-aec3-48a8-a518-76e4097f6479	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Redpharm Drug	57d1c333-c229-54aa-e063-6394a90a84ce	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	PD-Rx Pharmaceuticals, Inc.	73564b3d-8ede-4008-b75c-1277153b5bb6	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	PD-Rx Pharmaceuticals, Inc.	8a66d90e-5450-4716-8c01-e7dc1967d00d	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	PD-Rx Pharmaceuticals, Inc.	8cbe2215-744c-438a-b3d6-b7d6ae769231	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	be4aa233-1555-4972-858e-46343a710558	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	11d06acd-1351-4afd-a16a-f035758e2a27	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	ca194a2a-ed16-40f6-a78c-45c5f3392170	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	ebc4efec-7895-4298-8e75-360bb7992f8d	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	8f0291a9-c8a6-4298-a540-23abc01fae09	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Coupler LLC	56050192-c499-64bd-e063-6294a90acbeb	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
spironolactone	SPIRONOLACTONE	Camber Pharmaceuticals, Inc.	e61269b2-823a-49e8-b55f-ef0b8b1dbcde	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	ATLANTIC BIOLOGICALS CORP.	122558a0-57bb-4195-9adf-d37b049cbfb5	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Safecor Health LLC	7057c090-67c2-414c-9077-bed18ad4b0b3	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	6518ba72-89e4-4f2f-b334-9ef759b696f8	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Coupler LLC	53454970-2c0f-54c3-e063-6294a90aac0a	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	b119ed8a-289a-46c5-9778-6b07e4c061c4	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	31aeab13-8f71-49f1-b101-8b0abb21b0dc	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	PD-Rx Pharmaceuticals, Inc.	3487305c-25a6-4e82-923c-3e4dd638c988	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2672	Spironolactone	Spironolactone	Actavis Pharma, Inc.	ANDA	Current
0228-2673	Spironolactone	Spironolactone	Actavis Pharma, Inc.	ANDA	Current
0228-2803	Spironolactone	Spironolactone	Actavis Pharma, Inc.	ANDA	Current
0228-2803	Spironolactone	Spironolactone	Actavis Pharma, Inc.	ANDA	Current
0904-5951	Spironolactone	Spironolactone	Major Pharmaceuticals	ANDA	Current
42254-183	Spironolactone	Spironolactone	Rebel Distributors Corp	ANDA	Current
49999-811	Spironolactone	Spironolactone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50268-726	Spironolactone	Spironolactone	AvPAK	ANDA	Current
51655-838	SPIRONOLACTONE	SPIRONOLACTONE	Northwind Pharmaceuticals, LLC	ANDA	Current
53808-0796	Spironolactone	SPIRONOLACTONE	State of Florida DOH Central Pharmacy	ANDA	Current
68151-2776	Spironolactone	Spironolactone	Carilion Materials Management	ANDA	Current
68788-9124	Spironolactone	spironolactone	Preferred Pharmaceuticals, Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7634	ORIG	1999-07-29