Application 203253

Type: ANDA
Sponsor: JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	25MG	No	No
002	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	50MG	No	No
003	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	100MG	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	TE codes	Approval date
A203253-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23
A203253-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23
A203253-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203253-001	AB
A203253-002	AB
A203253-003	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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203253-001	AB	1	`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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	6518ba72-89e4-4f2f-b334-9ef759b696f8	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253 ndc (product): 70518-0665
Spironolactone	SPIRONOLACTONE	QPharma, Inc.	37066684-5b63-4d3e-ae6a-08c4b3edd7aa	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253 ndc (product): 42708-101
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	37b9bc61-2757-454a-935b-752d13eb7eb4	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	b5b129b8-aed9-4d94-a35e-e92647effbdb	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	574efac6-b2d9-4053-940c-552f01a69b2e	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253 ndc (product): 63629-2437
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253 ndc (product): 63629-2438
Spironolactone	SPIRONOLACTONE	Jubilant Cadista Pharmacuticals Inc.	c1c5fdab-3ff7-414b-8e25-beed8311b8ad	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253 ndc (product): 59746-216 ndc (product): 59746-217 ndc (product): 59746-218
Spironolactone	SPIRONOLACTONE	Jubilant Cadista Pharmacuticals Inc.	a7510768-8a52-4230-6aa0-b0d92d82588f	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253 ndc (product): 59746-216 ndc (product): 59746-217 ndc (product): 59746-218
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	5c2ae130-8e84-4c3f-b190-82691312fcbd	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253 ndc (product): 63187-841
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	caf9c845-63eb-40bd-8261-0582abdf705a	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253 ndc (product): 63187-861

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42708-101	Spironolactone	spironolactone	QPharma Inc	ANDA	Current
42708-101	Spironolactone	spironolactone	QPharma Inc	ANDA	Current
50090-2728	Spironolactone	spironolactone	A-S Medication Solutions	ANDA	Current
50090-3315	Spironolactone	spironolactone	A-S Medication Solutions	ANDA	Current
53217-240	Spironolactone	spironolactone	Aidarex Pharmaceuticals LLC	ANDA	Current
55700-587	Spironolactone	spironolactone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
59746-216	Spironolactone	spironolactone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-217	Spironolactone	spironolactone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-218	Spironolactone	spironolactone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
63187-841	Spironolactone	spironolactone	Proficient Rx LP	ANDA	Current
63187-841	Spironolactone	spironolactone	Proficient Rx LP	ANDA	Current
63187-841	Spironolactone	spironolactone	Proficient Rx LP	ANDA	Current
63187-861	Spironolactone	spironolactone	Proficient Rx LP	ANDA	Current
63187-861	Spironolactone	spironolactone	Proficient Rx LP	ANDA	Current
63629-2436	Spironolactone	spironolactone	Bryant Ranch Prepack	ANDA	Current
63629-2436	Spironolactone	spironolactone	Bryant Ranch Prepack	ANDA	Current
63629-2437	Spironolactone	spironolactone	Bryant Ranch Prepack	ANDA	Current
63629-2437	Spironolactone	spironolactone	Bryant Ranch Prepack	ANDA	Current
63629-2438	Spironolactone	spironolactone	Bryant Ranch Prepack	ANDA	Current
63629-2438	Spironolactone	spironolactone	Bryant Ranch Prepack	ANDA	Current
67296-1403	Spironolactone	Spironolactone	RedPharm Drug, Inc.	ANDA	Current
67296-1403	Spironolactone	Spironolactone	RedPharm Drug, Inc.	ANDA	Current
67296-1403	Spironolactone	Spironolactone	RedPharm Drug, Inc.	ANDA	Current
68071-3112	Spironolactone	spironolactone	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4073	Spironolactone	spironolactone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6895	Spironolactone	spironolactone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6895	Spironolactone	spironolactone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6900	Spironolactone	spironolactone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6900	Spironolactone	spironolactone	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0603	Spironolactone	spironolactone	REMEDYREPACK INC.	ANDA	Current
70518-0603	Spironolactone	spironolactone	REMEDYREPACK INC.	ANDA	Current
70518-0603	Spironolactone	spironolactone	REMEDYREPACK INC.	ANDA	Current
70518-0603	Spironolactone	spironolactone	REMEDYREPACK INC.	ANDA	Current
70518-0665	Spironolactone	spironolactone	REMEDYREPACK INC.	ANDA	Current
70518-0665	Spironolactone	spironolactone	REMEDYREPACK INC.	ANDA	Current