Application 203512
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203512-001 | SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | |
| A203512-002 | SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | |
| A203512-003 | SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203512-001 | AB |
| A203512-002 | AB |
| A203512-003 | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203512-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203512-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203512-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203512-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203512-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203512-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203512-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203512-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203512-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203512-001 | AB | 1 | 301d65b070ca… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | c0efa529-2870-4260-b604-2f30e2cbb87b | 2026-08-07 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | 3487305c-25a6-4e82-923c-3e4dd638c988 | 2026-05-28 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Bryant Ranch Prepack | 473dc80f-11b7-46bf-b0b4-7a271444fca2 | 2026-05-21 | Warnings, Adverse reactions | 203512 ANDA203512 71335-0401 |
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | c223a334-7383-429f-b8e3-a21200f16962 | 2026-05-21 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Bryant Ranch Prepack | 2ed347bc-a9f1-4800-99bc-9af9912ead1f | 2026-05-19 | Warnings, Adverse reactions | 203512 ANDA203512 71335-0304 |
| Spironolactone | SPIRONOLACTONE | Bryant Ranch Prepack | 650bf1c1-b7f1-4e5b-a9f0-3a2e31b98dd3 | 2026-05-14 | Warnings, Adverse reactions | 203512 ANDA203512 71335-0053 |
| Spironolactone | SPIRONOLACTONE | Northwind Health Company, LLC | ab3090fc-458c-17c1-e053-2995a90a6ffa | 2026-01-01 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Accord Healthcare, Inc. | 8a96e2c9-049a-43ab-abf3-21baedeb736f | 2025-12-01 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | NuCare Pharmaceuticals, Inc. | 540ee876-78fb-1792-e054-00144ff88e88 | 2024-07-10 | Boxed warning, Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | NuCare Pharmaceuticals,Inc. | 691bc5ca-5d5e-60c2-e053-2991aa0abb93 | 2024-06-07 | Boxed warning, Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Asclemed USA, Inc. | 31c42b3e-f076-49d9-aa61-6cef0dbb5543 | 2023-10-03 | Warnings, Adverse reactions | 203512 ANDA203512 76420-062 |
| Spironolactone | SPIRONOLACTONE | Proficient Rx LP | dffac5dc-a111-4095-a96c-54cc5c3866e5 | 2023-04-01 | Boxed warning, Warnings, Adverse reactions | 203512 ANDA203512 71205-146 71205-148 71205-147 |
| Spironolactone | SPIRONOLACTONE | A-S Medication Solutions | 791251af-d276-40fc-8c35-9d179b20e219 | 2023-02-06 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Aphena Pharma Solutions - Tennessee, LLC | f230f1fa-878e-4753-a16c-bf059b59cdef | 2017-06-16 | Boxed warning, Warnings, Adverse reactions | 203512 ANDA203512 71610-287 71610-288 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68788-7019 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7019 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7019 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7051 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7051 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7051 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7051 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7051 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7297 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc.. | ANDA | Current |
| 68788-7297 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc.. | ANDA | Current |
| 68788-7297 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc.. | ANDA | Current |
| 68788-7297 | Spironolactone | spironolactone | Preferred Pharmaceuticals Inc.. | ANDA | Current |
| 70518-0630 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0630 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0630 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0630 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1314 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1314 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1314 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1314 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1314 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1314 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1314 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1314 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1314 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1334 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1334 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1334 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1334 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1334 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1334 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1742 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1742 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1742 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1742 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1742 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1742 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1746 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1746 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1746 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1746 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1746 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1746 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2461 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2461 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2461 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2461 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2461 | Spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70934-256 | Spironolactone | spironolactone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-256 | Spironolactone | spironolactone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-367 | Spironolactone | spironolactone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-367 | Spironolactone | spironolactone | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-367 | Spironolactone | spironolactone | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-368 | Spironolactone | spironolactone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-368 | Spironolactone | spironolactone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-787 | Spironolactone | spironolactone | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71205-146 | Spironolactone | spironolactone | Proficient Rx LP | ANDA | Current |
| 71205-146 | Spironolactone | spironolactone | Proficient Rx LP | ANDA | Current |
| 71205-146 | Spironolactone | spironolactone | Proficient Rx LP | ANDA | Current |
| 71205-147 | Spironolactone | spironolactone | Proficient Rx LP | ANDA | Current |
| 71205-147 | Spironolactone | spironolactone | Proficient Rx LP | ANDA | Current |
| 71205-147 | Spironolactone | spironolactone | Proficient Rx LP | ANDA | Current |
| 71205-148 | Spironolactone | spironolactone | Proficient Rx LP | ANDA | Current |
| 71205-148 | Spironolactone | spironolactone | Proficient Rx LP | ANDA | Current |
| 71205-148 | Spironolactone | spironolactone | Proficient Rx LP | ANDA | Current |
| 71335-0053 | Spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0053 | Spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0053 | Spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0304 | Spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0304 | Spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0304 | Spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0401 | Spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0401 | Spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0401 | Spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1518 | Spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71610-287 | Spironolactone | spironolactone | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-288 | Spironolactone | spironolactone | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72189-329 | SPIRONOLACTONE | spironolactone | Direct Rx | ANDA | Current |
| 76420-062 | Spironolactone | spironolactone | Asclemed USA, Inc. | ANDA | Current |
| 76420-062 | Spironolactone | spironolactone | Asclemed USA, Inc. | ANDA | Current |