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 5 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
spironolactone	SPIRONOLACTONE	Camber Pharmaceuticals, Inc.	4ac2926a-949a-4383-b0b0-92c0822dfcda	2025-04-08	Warnings, Adverse reactions	Name fallback brand name: spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Asclemed USA, Inc.	db22e9e5-2d88-4712-a809-c00881edb447	2025-03-06	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	34b19a23-4595-417e-9592-fd1d69398e59	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	NuCare Pharmaceuticals, Inc.	2e5e782d-9ceb-d4a4-e063-6294a90aba3a	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	f98cc3be-cf59-e3d2-e053-6294a90a2ae0	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	f9b79b4a-1a48-6247-e053-6394a90a2ae1	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	99b119e3-537a-464c-9376-4219bf283753	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Direct_Rx	ffc2e9b4-1f0f-220c-e053-6294a90a6d75	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Direct_Rx	ffd1ed7a-b6a4-4240-e053-6394a90a7db1	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	Padagis US LLC	522bd365-ddcc-48f4-8a98-66dc4c3bb314	2025-01-01	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	a73e3dd9-4958-4a2c-853f-45b2810b1639	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	37b9bc61-2757-454a-935b-752d13eb7eb4	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	b5b129b8-aed9-4d94-a35e-e92647effbdb	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	574efac6-b2d9-4053-940c-552f01a69b2e	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
SPIRONOLACTONE	SPIRONOLACTONE	NCS HealthCare of KY, LLC dba Vangard Labs	e34fc3ca-1272-446b-8dc2-25b62add01c3	2024-08-05	Warnings, Adverse reactions	Name fallback brand name: SPIRONOLACTONE generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Jubilant Cadista Pharmacuticals Inc.	c1c5fdab-3ff7-414b-8e25-beed8311b8ad	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	Jubilant Cadista Pharmacuticals Inc.	a7510768-8a52-4230-6aa0-b0d92d82588f	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	NuCare Pharmaceuticals, Inc.	540ee876-78fb-1792-e054-00144ff88e88	2024-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Spironolactone generic name: SPIRONOLACTONE
Spironolactone	SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	691bc5ca-5d5e-60c2-e053-2991aa0abb93	2024-06-07	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.