Application 021437
- Type
- NDA
- Sponsor
- GD SEARLE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INSPRA | EPLERENONE | TABLET;ORAL | 25MG | Yes | No |
| 002 | INSPRA | EPLERENONE | TABLET;ORAL | 50MG | Yes | Yes |
| 003 | INSPRA | EPLERENONE | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021437-001 | INSPRA | EPLERENONE | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 |
| N021437-002 | INSPRA | EPLERENONE | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 |
| N021437-003 | INSPRA | EPLERENONE | 100MG | TABLET / ORAL | 2002-09-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021437-001 | AB |
| N021437-002 | 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 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021437-002 | INSPRA | 50MG | TABLET / ORAL | AB | RLD, RS | 2002-09-27 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021437-003 | INSPRA | 100MG | TABLET / ORAL | 2002-09-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N021437-001 | INSPRA | 25MG | TABLET / ORAL | AB | RLD | 2002-09-27 | 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 | N021437-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021437-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021437-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021437-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021437-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021437-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021437-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021437-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021437-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021437-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021437-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021437-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021437-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021437-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021437-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021437-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021437-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021437-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021437-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021437-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021437-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021437-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021437-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021437-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021437-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021437-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021437-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021437-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021437-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021437-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021437-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021437-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021437-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021437-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021437-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021437-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021437-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021437-002 | AB | 1 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6410524 | 2019-11-05 | U-467 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6747020 | 2019-11-05 | U-587 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6410054 | 2019-12-08 | U-3 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6410054 | 2019-12-08 | U-537 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6495165 | 2019-12-08 | U-3 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6495165 | 2019-12-08 | U-537 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6534093 | 2019-12-08 | U-3 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6534093 | 2019-12-08 | U-537 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6558707 | 2019-12-08 | U-537 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 7157101 | 2019-12-08 | U-664 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6410524*PED | 2020-05-05 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6747020*PED | 2020-05-05 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6410054*PED | 2020-06-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6495165*PED | 2020-06-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6534093*PED | 2020-06-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 6558707*PED | 2020-06-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-001 | 7157101*PED | 2020-06-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6410524 | 2019-11-05 | U-467 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6747020 | 2019-11-05 | U-587 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6410054 | 2019-12-08 | U-3 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6410054 | 2019-12-08 | U-537 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6495165 | 2019-12-08 | U-3 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6495165 | 2019-12-08 | U-537 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6534093 | 2019-12-08 | U-3 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6534093 | 2019-12-08 | U-537 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6558707 | 2019-12-08 | U-537 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 7157101 | 2019-12-08 | U-664 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6410524*PED | 2020-05-05 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6747020*PED | 2020-05-05 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6410054*PED | 2020-06-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6495165*PED | 2020-06-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6534093*PED | 2020-06-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 6558707*PED | 2020-06-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-002 | 7157101*PED | 2020-06-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-003 | 6410524 | 2019-11-05 | U-467 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-003 | 6747020 | 2019-11-05 | U-587 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-003 | 6410054 | 2019-12-08 | U-3 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-003 | 6410054 | 2019-12-08 | U-537 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-003 | 6495165 | 2019-12-08 | U-3 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021437-003 | 6495165 | 2019-12-08 | U-537 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Inspra | EPLERENONE | Viatris Specialty LLC | 1a52bedc-8e2c-4116-a296-a87770676b4a | 2025-06-23 | Warnings, Adverse reactions | 021437 NDA021437 |
| Eplerenone | EPLERENONE | Mylan Pharmaceuticals Inc. | 4286699b-2320-4d3d-831c-32085f36fb67 | 2025-06-23 | Warnings, Adverse reactions | 021437 NDA021437 |
| Eplerenone | EPLERENONE | Mylan Pharmaceuticals Inc. | 6d988699-95c2-46b9-8266-23fe7016f33b | 2020-08-27 | Warnings, Adverse reactions | 021437 NDA021437 59762-1720 59762-1710 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0025-1710 | Inspra | eplerenone | G.D. Searle LLC Division of Pfizer Inc | NDA | Current |
| 0025-1710 | Inspra | eplerenone | G.D. Searle LLC Division of Pfizer Inc | NDA | Current |
| 0025-1710 | Inspra | eplerenone | G.D. Searle LLC Division of Pfizer Inc | NDA | Current |
| 0025-1710 | Inspra | eplerenone | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1710 | Inspra | eplerenone | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1720 | Inspra | eplerenone | G.D. Searle LLC Division of Pfizer Inc | NDA | Current |
| 0025-1720 | Inspra | eplerenone | G.D. Searle LLC Division of Pfizer Inc | NDA | Current |
| 0025-1720 | Inspra | eplerenone | G.D. Searle LLC Division of Pfizer Inc | NDA | Current |
| 0025-1720 | Inspra | eplerenone | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1720 | Inspra | eplerenone | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 21695-797 | Inspra | eplerenone | Rebel Distributors Corp | NDA | Current |
| 59762-1710 | Eplerenone | eplerenone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1710 | Eplerenone | eplerenone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1710 | Eplerenone | eplerenone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1720 | Eplerenone | eplerenone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1720 | Eplerenone | eplerenone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1720 | Eplerenone | eplerenone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82592 | SUPPL | 2025-06-17 |
| 82588 | SUPPL | 2025-06-17 |
| 54393 | SUPPL | 2018-05-31 |
| 54384 | SUPPL | 2018-05-31 |
| 36928 | SUPPL | 2016-05-05 |
| 5377 | SUPPL | 2016-05-05 |
| 27782 | SUPPL | 2013-05-21 |
| 15471 | SUPPL | 2013-05-21 |
| 15469 | SUPPL | 2012-07-13 |
| 5375 | SUPPL | 2012-07-13 |
| 15470 | SUPPL | 2012-06-26 |
| 5376 | SUPPL | 2012-06-26 |
| 15468 | SUPPL | 2008-05-19 |
| 27781 | SUPPL | 2008-05-09 |
| 5374 | SUPPL | 2008-02-04 |
| 36927 | SUPPL | 2008-01-31 |
| 52936 | SUPPL | 2007-10-19 |
| 52935 | SUPPL | 2007-10-19 |
| 52934 | SUPPL | 2007-10-19 |
| 51717 | SUPPL | 2007-10-19 |
| 51716 | SUPPL | 2006-06-07 |
| 51715 | SUPPL | 2004-10-01 |
| 21658 | SUPPL | 2004-09-09 |
| 51713 | SUPPL | 2004-08-17 |
| 42165 | ORIG | 2004-06-07 |
| 15467 | SUPPL | 2003-10-10 |
| 5373 | SUPPL | 2003-10-07 |
| 51714 | SUPPL | 2003-03-21 |
| 36926 | ORIG | 2002-09-27 |
| 5372 | ORIG | 2002-09-27 |