Application 078296
- Type
- ANDA
- Sponsor
- LUPIN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOVASTATIN | LOVASTATIN | TABLET;ORAL | 10MG | No | No |
| 002 | LOVASTATIN | LOVASTATIN | TABLET;ORAL | 20MG | No | No |
| 003 | LOVASTATIN | LOVASTATIN | TABLET;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078296-001 | LOVASTATIN | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | |
| A078296-002 | LOVASTATIN | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | |
| A078296-003 | LOVASTATIN | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078296-001 | AB |
| A078296-002 | AB |
| A078296-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078296-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078296-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078296-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078296-001 | AB | 1 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| Lovastatin | LOVASTATIN | PD-Rx Pharmaceuticals, Inc. | e75b5808-ec66-4da7-90bc-e53611aa1b34 | 2026-06-12 | Warnings, Adverse reactions | 078296 ANDA078296 55289-692 |
| Lovastatin | LOVASTATIN | Preferred Pharmaceuticals, Inc. | 397949f9-ce60-424f-9902-90e65a34f4de | 2026-06-03 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Preferred Pharmaceuticals, Inc. | 22c9f2d8-7bcd-4415-bbc8-505720033966 | 2026-06-03 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Bryant Ranch Prepack | 030c0f79-6bb5-4876-bf8e-b7a25b25dd38 | 2026-05-29 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Bryant Ranch Prepack | f5f265a6-2aa5-4205-9159-40133ae93ac0 | 2026-05-28 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | BluePoint Laboratories | 7b86160d-74a9-4774-b5b3-5641e686991f | 2026-05-27 | Warnings, Adverse reactions | 078296 ANDA078296 68001-314 68001-316 68001-315 |
| Lovastatin | LOVASTATIN | REMEDYREPACK INC. | ff040b3c-6790-40d7-bd64-a4073b4a2045 | 2026-05-21 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Lupin Pharmaceuticals, Inc. | df7ddf4f-d569-431e-81f1-9129d7043150 | 2026-05-06 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Legacy Pharmaceutical Packaging, LLC | a4f02fa1-3281-46fa-bd52-323e2644b6f8 | 2026-03-11 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Northwind Health Company, LLC | f308fe1c-23a9-6409-e053-2995a90abfd9 | 2026-01-01 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Northwind Health Company, LLC | ca59cbd4-a4c1-aebe-e053-2a95a90ae968 | 2026-01-01 | Warnings, Adverse reactions | 078296 ANDA078296 51655-558 |
| Lovastatin | LOVASTATIN | Northwind Health Company, LLC | f99e0b4c-e757-4ccd-e053-6294a90ab722 | 2026-01-01 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | A-S Medication Solutions | 06b8c398-ce2e-42c1-b1a8-73cc59a080db | 2025-10-15 | Warnings, Adverse reactions | 078296 ANDA078296 50090-3396 |
| Lovastatin | LOVASTATIN | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 2eeb34ac-f973-e7d9-e063-6294a90a076e | 2025-02-24 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | NuCare Pharmaceuticals, Inc. | 50217921-97a7-6ff2-e054-00144ff88e88 | 2025-02-04 | Warnings, Adverse reactions | 078296 ANDA078296 68071-3261 |
| Lovastatin | LOVASTATIN | A-S Medication Solutions | 02aae38d-ee9d-4c09-a155-b69f221ed3e9 | 2024-10-15 | Warnings, Adverse reactions | 078296 ANDA078296 50090-0762 50090-0759 |
| Lovastatin | LOVASTATIN | NCS HealthCare of KY, LLC dba Vangard Labs | 3af47e72-082d-42ad-bde0-294f8101b45c | 2024-08-05 | Warnings, Adverse reactions | 078296 ANDA078296 0615-8152 0615-8151 |
| Lovastatin | LOVASTATIN | NuCare Pharmaceuticals,Inc. | 19b2bb87-1dc7-cd72-e063-6394a90a0f73 | 2024-06-18 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | NuCare Pharmaceuticals,Inc. | 1ac7ffb9-860a-fbb6-e063-6294a90a590f | 2024-06-13 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Proficient Rx LP | 2b53ab6a-5770-4fd7-9aa1-f4273d4bdaeb | 2022-12-01 | Warnings, Adverse reactions | 078296 ANDA078296 63187-765 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8151 | Lovastatin | lovastatin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8151 | Lovastatin | lovastatin | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8152 | Lovastatin | lovastatin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8152 | Lovastatin | lovastatin | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 21695-534 | Lovastatin | Lovastatin | Rebel Distributors Corp | ANDA | Current |
| 21695-535 | Lovastatin | Lovastatin | Rebel Distributors Corp | ANDA | Current |
| 21695-536 | Lovastatin | Lovastatin | Rebel Distributors Corp | ANDA | Current |
| 43063-493 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-493 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-493 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-493 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-493 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 49999-471 | Lovastatin | Lovastatin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-471 | Lovastatin | Lovastatin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-0759 | Lovastatin | lovastatin | A-S Medication Solutions | ANDA | Current |
| 50090-0759 | Lovastatin | lovastatin | A-S Medication Solutions | ANDA | Current |
| 50090-0762 | Lovastatin | lovastatin | A-S Medication Solutions | ANDA | Current |
| 50090-0762 | Lovastatin | lovastatin | A-S Medication Solutions | ANDA | Current |
| 50090-0762 | Lovastatin | lovastatin | A-S Medication Solutions | ANDA | Current |
| 50090-3396 | Lovastatin | lovastatin | A-S Medication Solutions | ANDA | Current |
| 50090-3396 | Lovastatin | lovastatin | A-S Medication Solutions | ANDA | Current |
| 50090-3396 | Lovastatin | lovastatin | A-S Medication Solutions | ANDA | Current |
| 51655-558 | Lovastatin | lovastatin | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53002-1385 | Lovastatin | lovastatin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1385 | Lovastatin | lovastatin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-304 | Lovastatin | lovastatin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 54458-936 | LOVASTATIN | LOVASTATIN | International Laboratories, LLC | ANDA | Current |
| 54458-936 | LOVASTATIN | LOVASTATIN | International Laboratories, LLC | ANDA | Current |
| 54458-937 | LOVASTATIN | LOVASTATIN | International Laboratories, LLC | ANDA | Current |
| 54458-937 | LOVASTATIN | LOVASTATIN | International Laboratories, LLC | ANDA | Current |
| 54458-938 | LOVASTATIN | LOVASTATIN | International Laboratories, LLC | ANDA | Current |
| 54458-938 | LOVASTATIN | LOVASTATIN | International Laboratories, LLC | ANDA | Current |
| 55289-692 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-692 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-692 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-692 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-692 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-692 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-881 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-881 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-881 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-881 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-881 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-881 | Lovastatin | lovastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55700-244 | Lovastatin | lovastatin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-244 | Lovastatin | lovastatin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 61919-311 | LOVASTATIN | LOVASTATIN | Direct Rx | ANDA | Current |
| 61919-311 | LOVASTATIN | LOVASTATIN | Direct Rx | ANDA | Current |
| 61919-311 | LOVASTATIN | LOVASTATIN | Direct Rx | ANDA | Current |
| 63187-765 | Lovastatin | lovastatin | Proficient Rx LP | ANDA | Current |
| 63187-765 | Lovastatin | lovastatin | Proficient Rx LP | ANDA | Current |
| 63187-765 | Lovastatin | lovastatin | Proficient Rx LP | ANDA | Current |
| 63187-765 | Lovastatin | lovastatin | Proficient Rx LP | ANDA | Current |
| 63187-814 | Lovastatin | lovastatin | Proficient Rx LP | ANDA | Current |
| 63187-814 | Lovastatin | lovastatin | Proficient Rx LP | ANDA | Current |
| 63629-6346 | Lovastatin | lovastatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6346 | Lovastatin | lovastatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6386 | Lovastatin | lovastatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6386 | Lovastatin | lovastatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6436 | Lovastatin | lovastatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6436 | Lovastatin | lovastatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6436 | Lovastatin | lovastatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6436 | Lovastatin | lovastatin | Bryant Ranch Prepack | ANDA | Current |
| 68001-314 | Lovastatin | lovastatin | BluePoint Laboratories | ANDA | Current |
| 68001-314 | Lovastatin | lovastatin | BluePoint Laboratories | ANDA | Current |
| 68001-314 | Lovastatin | lovastatin | BluePoint Laboratories | ANDA | Current |
| 68001-315 | Lovastatin | lovastatin | BluePoint Laboratories | ANDA | Current |
| 68001-315 | Lovastatin | lovastatin | BluePoint Laboratories | ANDA | Current |
| 68001-315 | Lovastatin | lovastatin | BluePoint Laboratories | ANDA | Current |
| 68001-316 | Lovastatin | lovastatin | BluePoint Laboratories | ANDA | Current |
| 68001-316 | Lovastatin | lovastatin | BluePoint Laboratories | ANDA | Current |
| 68001-316 | Lovastatin | lovastatin | BluePoint Laboratories | ANDA | Current |
| 68071-1880 | Lovastatin | lovastatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1880 | Lovastatin | lovastatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3261 | Lovastatin | lovastatin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3261 | Lovastatin | lovastatin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3261 | Lovastatin | lovastatin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4271 | Lovastatin | lovastatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4271 | Lovastatin | lovastatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4271 | Lovastatin | lovastatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |