Application 086898

Type: ANDA
Sponsor: WATSON LABS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A086898-002	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL			1982-03-02

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086898-002	SPIRONOLACTONE	25MG	TABLET / ORAL	1982-03-02	`3a93d1ddd44b…`

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 6 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	781e0f31-a7c8-4a05-bb38-88f6dd874746	2024-02-08	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	985524c3-9fb3-4874-9eb6-80b17af3d8ed	2023-12-17	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	7ef0c2bb-9657-419e-848c-858893be50bc	2023-12-17	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Aphena Pharma Solutions - Tennessee, LLC	fb961096-edbb-45ad-96b7-61c2f9b98cf9	2023-10-31	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Asclemed USA, Inc.	31c42b3e-f076-49d9-aa61-6cef0dbb5543	2023-10-03	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Amneal Pharmaceuticals NY LLC	1ed9a2cb-d666-43db-b515-f9615fa6da25	2023-08-30	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	A-S Medication Solutions	15641f17-a08e-432b-ab8f-13db623e612e	2023-08-28	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Proficient Rx LP	416ce231-fc8d-4ba0-a1ce-d5e054cf025e	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	be568fbd-3c3d-417c-ae96-75a78ca4b7cd	2023-06-02	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	4514fa40-613e-46f5-bee4-3edc7cc9863f	2023-04-16	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	200b2a6a-f263-463e-a2e1-f4f74058a924	2023-04-07	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Asclemed USA, Inc.	731894f2-bb1b-4ff6-b8c4-b8722e173199	2023-04-07	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	dffac5dc-a111-4095-a96c-54cc5c3866e5	2023-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Proficient Rx LP	18f11eed-9ef6-43f6-8db0-720c27563871	2023-04-01	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	A-S Medication Solutions	791251af-d276-40fc-8c35-9d179b20e219	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	PharmPak, Inc.	c450e66a-0f05-445e-b1df-df2b17a2f064	2022-10-14	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	5c2ae130-8e84-4c3f-b190-82691312fcbd	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Aphena Pharma Solutions - Tennessee, LLC	1c97ce61-8e49-4724-a636-d179479d346c	2021-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Amneal Pharmaceuticals LLC	fb66327e-8261-46ae-b39a-4fa79d520844	2020-11-30	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	caf9c845-63eb-40bd-8261-0582abdf705a	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.