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 3 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	2d0655d7-fda6-40c6-907c-acaba0e19987	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	PD-Rx Pharmaceuticals, Inc.	c223a334-7383-429f-b8e3-a21200f16962	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	1c31c953-05ce-475a-b93f-80aeb12bde95	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	2ed347bc-a9f1-4800-99bc-9af9912ead1f	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	10a5c989-66e3-494d-bfd8-b2d6df3be411	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	650bf1c1-b7f1-4e5b-a9f0-3a2e31b98dd3	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	QPharma, Inc	eb314e91-6dd5-4bdb-af35-5d147b20339c	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	6782c1c1-d1ac-4c07-b7cb-a74699d2f9fe	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	cae68fd6-5161-4650-bcde-6db98cbe6c8b	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	b7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	6867776e-b4fd-41db-8da8-a5af76eed280	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	3791d79c-d960-4790-b689-ea32ddf7226a	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	cbc817de-5ea8-4139-9c13-02bac8ff93c3	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	ce792c44-421d-4274-a333-01e2297ee0a3	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Mylan Pharmaceuticals Inc.	beaf74db-4159-3b59-ef99-575c3ac99aa1	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Rising Pharma Holdings, Inc.	ac487ae2-e15f-4781-bae3-a03058cfcfe4	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Direct_Rx	ffd2f3f5-c7c8-0028-e053-6394a90aaf17	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	4b9a20c4-46f2-d572-e063-6294a90a30ad	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	NuCare Pharmaceuticals, Inc.	4b4af7e0-f35b-9bf6-e063-6294a90a83b9	2026-02-20	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Oxford Pharmaceuticals, LLC	852684dc-e1c6-4caa-bccb-10ac90bbb3bb	2026-02-17	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.