Application 089424

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPIRONOLACTONESPIRONOLACTONETABLET;ORAL25MGNoNo
002SPIRONOLACTONESPIRONOLACTONETABLET;ORAL50MGNoNo
003SPIRONOLACTONESPIRONOLACTONETABLET;ORAL100MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089424-001SPIRONOLACTONESPIRONOLACTONE25MGTABLET / ORALAB1986-07-23
A089424-002SPIRONOLACTONESPIRONOLACTONE50MGTABLET / ORALAB1999-08-11
A089424-003SPIRONOLACTONESPIRONOLACTONE100MGTABLET / ORALAB1999-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089424-001AB
A089424-002AB
A089424-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2384e616aacf4f…
2026-09-14 22:38:342026-08A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1184e616aacf4f…
2026-08-18 06:07:402026-07A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A089424-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A089424-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A089424-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A089424-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089424-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089424-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089424-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089424-001AB1301d65b070ca…

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack3b60de71-2afa-4922-ba3e-0664c2ae29a02026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackd6138536-cdc1-4459-84ff-9dedc0de11052026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackcaf41e17-0461-4667-9eab-62853b9451312026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepacka6e0bf0e-42d3-41e4-854b-811df3bbaaa92026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1fe93db1-0012-4ff6-a4e6-04e2d7e9f6382026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1b29888c-09f9-4cd5-9b4c-920bd159a7272026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackb98b7780-e310-493a-83bd-bb3d93cf8dde2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack753bbc6f-2e50-49c1-b5bf-18f8411a1e8e2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
ndc (product): 63629-8539
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack0cc23419-e6d5-4036-8011-dc1d2455e0cb2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
ndc (product): 63629-1094
SPIRONOLACTONESPIRONOLACTONEREMEDYREPACK INC.7c59e03a-b058-4f6e-b104-0836d9b563922026-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEPreferred Pharmaceuticals Inc.3486d831-06b6-4e8f-bd6f-52f7759988f52026-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONESun Pharmaceutical Industries, Inc.c23b6b9b-aec3-48a8-a518-76e4097f64792026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackbe4aa233-1555-4972-858e-46343a7105582026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack11d06acd-1351-4afd-a16a-f035758e2a272026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackca194a2a-ed16-40f6-a78c-45c5f33921702026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackebc4efec-7895-4298-8e75-360bb7992f8d2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack813d199a-9004-4102-8ade-cf877caedafb2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackbb1423e8-1517-44c5-98e0-99be24ce269b2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack2d0655d7-fda6-40c6-907c-acaba0e199872026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1c31c953-05ce-475a-b93f-80aeb12bde952026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424

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 2 of 2 · 114 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-1094SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-1094SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-1094SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-1095SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-1095SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-1095SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-1095SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-1095SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-1830SpironolactonespironolactoneBryant Ranch PrepackANDACurrent
63629-1830SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-1830SpironolactoneSPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-4094SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-4094SpironolactonespironolactoneBryant Ranch PrepackANDACurrent
63629-4094SpironolactoneSPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-5341SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-5341SpironolactonespironolactoneBryant Ranch PrepackANDACurrent
63629-5341SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-8539SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-8539SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-8539SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63629-9182SPIRONOLACTONESPIRONOLACTONEBryant Ranch PrepackANDACurrent
63739-416SpironolactonespironolactoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-416SpironolactonespironolactoneMcKesson CorporationANDACurrent
66267-476SpironolactonespironolactoneNuCare Pharmaceuticals, Inc.ANDACurrent
66267-476SpironolactonespironolactoneNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1992SpironolactonespironolactoneNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6332SpironolactonespironolactonePreferred Pharmaceuticals Inc.ANDACurrent
68788-6332SpironolactonespironolactonePreferred Pharmaceuticals Inc.ANDACurrent
68788-9227SpironolactonespironolactonePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0563SpironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-0563SpironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-0563SPIRONOLACTONESPIRONOLACTONEREMEDYREPACK INC.ANDACurrent
70518-0563SPIRONOLACTONESPIRONOLACTONEREMEDYREPACK INC.ANDACurrent
70518-3118SPIRONOLACTONESPIRONOLACTONEREMEDYREPACK INC.ANDACurrent