Application 205936

Type
ANDA
Sponsor
ZYDUS PHARMS

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 1.

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
A205936-001SPIRONOLACTONESPIRONOLACTONE25MGTABLET / ORALAB2018-07-18
A205936-002SPIRONOLACTONESPIRONOLACTONE50MGTABLET / ORALAB2018-07-18
A205936-003SPIRONOLACTONESPIRONOLACTONE100MGTABLET / ORALAB2018-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205936-001AB
A205936-002AB
A205936-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-188072bd15b7f6…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205936-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205936-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205936-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205936-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205936-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205936-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205936-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205936-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205936-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205936-001AB18072bd15b7f6…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
spironolactoneSPIRONOLACTONEREMEDYREPACK INC.8b76a904-6c99-485a-a05f-13a36c5f720c2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONECardinal Health 107, LLC96db5dee-7c01-4f96-8b1e-1fcd2103d0fe2026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
ndc (product): 55154-3556
spironolactoneSPIRONOLACTONENorthwind Health Company, LLCf988aa11-60ed-411e-e053-6294a90a522a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONENorthwind Health Company, LLCf32e8109-73e1-a249-e053-2995a90a3fae2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONENorthwind Health Company, LLCf76b37a6-bcd4-2c8a-e053-6394a90aceea2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONEREMEDYREPACK INC.eb27a2d2-1d28-4780-8e69-5fe613a0335e2025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONEMajor Pharmaceuticals0c45d793-6f2f-4622-b5ed-6875acfbc02b2025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
ndc (product): 0904-6927
spironolactoneSPIRONOLACTONEZydus Lifesciences Limited963af399-feb7-49d2-a59c-c19edad9c6822025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
ndc (product): 70771-1029
ndc (product): 70771-1027
ndc (product): 70771-1028
spironolactoneSPIRONOLACTONEZydus Pharmaceuticals (USA) Inc.99bbc053-0e41-4b4d-979a-db610908f2de2025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
ndc (product): 68382-660
ndc (product): 68382-662
ndc (product): 68382-661
spironolactoneSPIRONOLACTONEREMEDYREPACK INC.39d82d50-0b77-4ef5-96b8-c1e05044a82c2025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
SpironolactoneSPIRONOLACTONEAmerican Health Packagingbd5ec154-b092-4c4d-8e72-ca2a2ef71a6d2024-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
ndc (product): 60687-487
ndc (product): 60687-465
ndc (product): 60687-476

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6927spironolactonespironolactoneMajor PharmaceuticalsANDACurrent
0904-6927spironolactonespironolactoneMajor PharmaceuticalsANDACurrent
55154-3556spironolactonespironolactoneCardinal Health 107, LLCANDACurrent
55700-713spironolactonespironolactoneQuality Care Products, LLCANDACurrent
55700-713spironolactonespironolactoneQuality Care Products, LLCANDACurrent
55700-934spironolactonespironolactoneQuality Care Products, LLCANDACurrent
60687-465SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-465SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-465SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-476SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-476SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-476SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-487SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-487SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-487SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
67296-1692spironolactonespironolactoneRedPharm Drug, Inc.ANDACurrent
67296-1692spironolactonespironolactoneRedPharm Drug, Inc.ANDACurrent
68382-660spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-660spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-660spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-660spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-660spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-661spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-661spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-661spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-661spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-661spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-662spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-662spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-662spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-662spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-662spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
70518-2384spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2384spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2384spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2385spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2385spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2385spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2386spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2386spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2386spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2585spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2585spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2585spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2585spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2585spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2588spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2588spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2588spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2588spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2589spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2589spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2589spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2589spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2589spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70771-1027spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1027spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1027spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1027spironolactonespironolactoneZydus Lifesciences LimitedANDACurrent
70771-1027spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1028spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1028spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1028spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1028spironolactonespironolactoneZydus Lifesciences LimitedANDACurrent
70771-1028spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1029spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1029spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1029spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1029spironolactonespironolactoneZydus Lifesciences LimitedANDACurrent
70771-1029spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
71335-1546spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1546spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1546spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1546spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1546spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1586spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1586spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1586spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1604spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1604spironolactonespironolactoneBryant Ranch PrepackANDACurrent