Application 205936
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
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 |
|---|---|---|---|---|---|---|---|
| A205936-001 | SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | |
| A205936-002 | SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | |
| A205936-003 | SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205936-001 | AB |
| A205936-002 | AB |
| A205936-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205936-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2018-07-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205936-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2018-07-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205936-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2018-07-18 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205936-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205936-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205936-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205936-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205936-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205936-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205936-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205936-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205936-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205936-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205936-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205936-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205936-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205936-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205936-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205936-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205936-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205936-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205936-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205936-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205936-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205936-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205936-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205936-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205936-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205936-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205936-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205936-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205936-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205936-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205936-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205936-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205936-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205936-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205936-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205936-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205936-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205936-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205936-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205936-001 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| spironolactone | SPIRONOLACTONE | REMEDYREPACK INC. | 8b76a904-6c99-485a-a05f-13a36c5f720c | 2026-08-04 | Warnings, Adverse reactions | 205936 ANDA205936 |
| spironolactone | SPIRONOLACTONE | Cardinal Health 107, LLC | 96db5dee-7c01-4f96-8b1e-1fcd2103d0fe | 2026-01-22 | Warnings, Adverse reactions | 205936 ANDA205936 55154-3556 |
| spironolactone | SPIRONOLACTONE | Northwind Health Company, LLC | f988aa11-60ed-411e-e053-6294a90a522a | 2026-01-01 | Warnings, Adverse reactions | 205936 ANDA205936 |
| spironolactone | SPIRONOLACTONE | Northwind Health Company, LLC | f32e8109-73e1-a249-e053-2995a90a3fae | 2026-01-01 | Warnings, Adverse reactions | 205936 ANDA205936 |
| spironolactone | SPIRONOLACTONE | Northwind Health Company, LLC | f76b37a6-bcd4-2c8a-e053-6394a90aceea | 2026-01-01 | Warnings, Adverse reactions | 205936 ANDA205936 |
| spironolactone | SPIRONOLACTONE | REMEDYREPACK INC. | eb27a2d2-1d28-4780-8e69-5fe613a0335e | 2025-12-29 | Warnings, Adverse reactions | 205936 ANDA205936 |
| spironolactone | SPIRONOLACTONE | Major Pharmaceuticals | 0c45d793-6f2f-4622-b5ed-6875acfbc02b | 2025-12-29 | Warnings, Adverse reactions | 205936 ANDA205936 0904-6927 |
| spironolactone | SPIRONOLACTONE | Zydus Lifesciences Limited | 963af399-feb7-49d2-a59c-c19edad9c682 | 2025-12-08 | Warnings, Adverse reactions | 205936 ANDA205936 70771-1029 70771-1027 70771-1028 |
| spironolactone | SPIRONOLACTONE | Zydus Pharmaceuticals (USA) Inc. | 99bbc053-0e41-4b4d-979a-db610908f2de | 2025-12-08 | Warnings, Adverse reactions | 205936 ANDA205936 68382-660 68382-662 68382-661 |
| spironolactone | SPIRONOLACTONE | REMEDYREPACK INC. | 39d82d50-0b77-4ef5-96b8-c1e05044a82c | 2025-09-09 | Warnings, Adverse reactions | 205936 ANDA205936 |
| Spironolactone | SPIRONOLACTONE | American Health Packaging | bd5ec154-b092-4c4d-8e72-ca2a2ef71a6d | 2024-10-17 | Warnings, Adverse reactions | 205936 ANDA205936 60687-487 60687-465 60687-476 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6927 | spironolactone | spironolactone | Major Pharmaceuticals | ANDA | Current |
| 0904-6927 | spironolactone | spironolactone | Major Pharmaceuticals | ANDA | Current |
| 55154-3556 | spironolactone | spironolactone | Cardinal Health 107, LLC | ANDA | Current |
| 55700-713 | spironolactone | spironolactone | Quality Care Products, LLC | ANDA | Current |
| 55700-713 | spironolactone | spironolactone | Quality Care Products, LLC | ANDA | Current |
| 55700-934 | spironolactone | spironolactone | Quality Care Products, LLC | ANDA | Current |
| 60687-465 | Spironolactone | Spironolactone | American Health Packaging | ANDA | Current |
| 60687-465 | Spironolactone | Spironolactone | American Health Packaging | ANDA | Current |
| 60687-465 | Spironolactone | Spironolactone | American Health Packaging | ANDA | Current |
| 60687-476 | Spironolactone | Spironolactone | American Health Packaging | ANDA | Current |
| 60687-476 | Spironolactone | Spironolactone | American Health Packaging | ANDA | Current |
| 60687-476 | Spironolactone | Spironolactone | American Health Packaging | ANDA | Current |
| 60687-487 | Spironolactone | Spironolactone | American Health Packaging | ANDA | Current |
| 60687-487 | Spironolactone | Spironolactone | American Health Packaging | ANDA | Current |
| 60687-487 | Spironolactone | Spironolactone | American Health Packaging | ANDA | Current |
| 67296-1692 | spironolactone | spironolactone | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1692 | spironolactone | spironolactone | RedPharm Drug, Inc. | ANDA | Current |
| 68382-660 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-660 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-660 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-660 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-660 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-661 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-661 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-661 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-661 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-661 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-662 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-662 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-662 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-662 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-662 | spironolactone | spironolactone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70518-2384 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2384 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2384 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2385 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2385 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2385 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2386 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2386 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2386 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2585 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2585 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2585 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2585 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2585 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2588 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2588 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2588 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2588 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2589 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2589 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2589 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2589 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2589 | spironolactone | spironolactone | REMEDYREPACK INC. | ANDA | Current |
| 70771-1027 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1027 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1027 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1027 | spironolactone | spironolactone | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1027 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1028 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1028 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1028 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1028 | spironolactone | spironolactone | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1028 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1029 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1029 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1029 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1029 | spironolactone | spironolactone | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1029 | spironolactone | spironolactone | Cadila Healthcare Limited | ANDA | Current |
| 71335-1546 | spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1546 | spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1546 | spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1546 | spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1546 | spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1586 | spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1586 | spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1586 | spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1604 | spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1604 | spironolactone | spironolactone | Bryant Ranch Prepack | ANDA | Current |