Application 206679
- Type
- NDA
- Sponsor
- TCG FLUENT PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLOLIPID | SIMVASTATIN | SUSPENSION;ORAL | 20MG/5ML | Yes | No |
| 002 | FLOLIPID | SIMVASTATIN | SUSPENSION;ORAL | 40MG/5ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N206679-001 | FLOLIPID | SIMVASTATIN | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | |
| N206679-002 | FLOLIPID | SIMVASTATIN | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N206679-001 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | |
| N206679-001 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | |
| N206679-002 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | |
| N206679-002 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N206679-001 | FLOLIPID | 20MG/5ML | SUSPENSION / ORAL | RLD | 2016-04-21 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N206679-002 | FLOLIPID | 40MG/5ML | SUSPENSION / ORAL | RLD, RS | 2016-04-21 | 4b0b4de00fa7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N206679-001 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N206679-001 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N206679-002 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N206679-002 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N206679-001 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N206679-001 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N206679-002 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N206679-002 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N206679-001 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N206679-001 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N206679-002 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N206679-002 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206679-001 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206679-001 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206679-002 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206679-002 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206679-001 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206679-001 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206679-002 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206679-002 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N206679-001 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N206679-001 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N206679-002 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N206679-002 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206679-001 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206679-001 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206679-002 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206679-002 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206679-001 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206679-001 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206679-002 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206679-002 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206679-001 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206679-001 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206679-002 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206679-002 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206679-001 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206679-001 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206679-002 | 10300041 | 2027-04-26 | Drug product | 2019-10-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206679-002 | 9597289 | 2030-02-23 | Drug product | 2017-04-21 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | Preferred Pharmaceuticals, Inc. | 68f6c856-ea98-4872-b4df-a6e9e70444fc | 2026-08-31 | Warnings, Adverse reactions | SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Preferred Pharmaceuticals, Inc. | 3f6fad0b-0278-433f-86db-761b673a5803 | 2026-08-31 | Warnings, Adverse reactions | SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Preferred Pharmaceuticals, Inc. | e73ec981-e477-4412-befd-7b807aceb32e | 2026-08-31 | Warnings, Adverse reactions | SIMVASTATIN |
| Simvastatin | SIMVASTATIN | REMEDYREPACK INC. | 593f0007-9690-4de5-b1e9-59299e587643 | 2026-08-27 | Warnings, Adverse reactions | SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Cardinal Health 107, LLC | b2d6c7ac-304b-4cba-974c-d9a23a069925 | 2026-08-25 | Warnings, Adverse reactions | SIMVASTATIN |
| Simvastatin | SIMVASTATIN | REMEDYREPACK INC. | d053fee4-b797-4a82-8865-0b4d08b14990 | 2026-08-19 | Warnings, Adverse reactions | SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Aphena Pharma Solutions - Tennessee, LLC | 58cd6c9a-3429-24eb-e063-6394a90a6984 | 2026-08-11 | Warnings, Adverse reactions | SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | REMEDYREPACK INC. | e59bf31f-d880-4d9e-b6c2-5a18a53718f9 | 2026-08-06 | Warnings, Adverse reactions | SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | e447cc46-adee-4126-8b85-f00f81a6e93c | 2026-07-08 | Warnings, Adverse reactions | SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Aphena Pharma Solutions - Tennessee, LLC | 55f92c72-e690-85dd-e063-6394a90adb39 | 2026-07-06 | Warnings, Adverse reactions | SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | f94d5907-737e-df67-e053-6394a90a82a6 | 2026-07-01 | Warnings, Adverse reactions | SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Bryant Ranch Prepack | a3bfe314-1fe4-4d2a-aecb-4194f3bd8f22 | 2026-06-29 | Warnings, Adverse reactions | SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | faa81817-3ffa-b83c-e053-6294a90a3f85 | 2026-06-02 | Warnings, Adverse reactions | SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | f94e5e28-f0b1-700a-e053-6394a90adb7b | 2026-06-01 | Warnings, Adverse reactions | SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Coupler LLC | 5257271e-5c07-4996-e063-6394a90a4424 | 2026-05-21 | Warnings, Adverse reactions | SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Coupler LLC | 52573b98-6e51-9753-e063-6294a90ac8c4 | 2026-05-21 | Warnings, Adverse reactions | SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | REMEDYREPACK INC. | 5ae78a86-ccca-4714-b77e-7bc885b674b5 | 2026-05-20 | Warnings, Adverse reactions | SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Aphena Pharma Solutions - Tennessee, LLC | 522d0f7f-f20b-bc17-e063-6294a90a3648 | 2026-05-19 | Warnings, Adverse reactions | SIMVASTATIN |
| simvastatin | SIMVASTATIN | PD-Rx Pharmaceuticals, Inc. | aa8aed58-691b-472e-8e98-53d0d3f56686 | 2026-05-12 | Warnings, Adverse reactions | SIMVASTATIN |
| simvastatin | SIMVASTATIN | PD-Rx Pharmaceuticals, Inc. | 7463b093-c2ee-49c3-a08a-e758de66422a | 2026-05-12 | Warnings, Adverse reactions | SIMVASTATIN |
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 |
|---|---|---|---|---|---|
| 29273-401 | FloLipid | Simvastatin | Salerno Pharmaceuticals Co. | NDA | Current |
| 29273-401 | FloLipid | Simvastatin | Salerno Pharmaceuticals Co. | NDA | Current |
| 29273-401 | FloLipid | Simvastatin | Salerno Pharmaceuticals Co. | NDA | Current |
| 29273-402 | FloLipid | Simvastatin | Salerno Pharmaceuticals Co. | NDA | Current |
| 29273-402 | FloLipid | Simvastatin | Salerno Pharmaceuticals Co. | NDA | Current |
| 29273-402 | FloLipid | Simvastatin | Salerno Pharmaceuticals Co. | NDA | Current |
| 73308-354 | SIMVASTATIN | Simvastatin | Ayurax | NDA | Current |