Application 086513

Type: ANDA
Sponsor: MYLAN

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086513-001	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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A086513-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086513-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086513-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086513-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086513-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086513-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086513-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086513-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086513-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086513-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086513-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086513-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086513-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086513-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086513-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086513-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086513-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086513-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086513-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086513-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086513-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086513-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086513-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086513-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086513-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086513-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086513-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086513-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086513-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086513-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086513-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086513-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086513-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086513-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086513-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086513-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086513-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086513-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086513-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086513-001	AB	1	`f41ea6bd6efb…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spironolactone and Hydrochlorothiazide	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	Safecor Health LLC	6fa96947-f4d8-4ca4-98fd-a2c123310d83	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086513 application number: ANDA086513
Spironolactone and Hydrochlorothiazide	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	Mylan Pharmaceuticals Inc.	0c8c973f-13a2-4883-8316-4006398e2931	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086513 application number: ANDA086513 ndc (product): 0378-0403
Spironolactone and Hydrochlorothiazide	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	Mylan Institutional Inc.	f2a4fbc0-650b-440d-9555-c1720fe0fe35	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086513 application number: ANDA086513 ndc (product): 42292-017

Reported adverse events (FAERS/openFDA)#

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

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
0378-0141	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0141	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
42292-017	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Institutional Inc.	ANDA	Current
42292-017	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Institutional Inc.	ANDA	Current
42292-017	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Institutional Inc.	ANDA	Current