Home Applications 078296 Application 078296
Type ANDA
Sponsor LUPIN Application Products# Product, Drug, Ingredient table 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table 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# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 4 · 132 observed states.
Captured, Edition, Application-product table 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 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
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.
Matched openFDA labels page 2 of 2 · 21 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 2 of 2 · 129 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68180-467 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68180-467 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68180-467 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68180-467 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68180-468 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68180-468 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68180-468 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68180-468 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68180-469 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68180-469 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68180-469 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68180-469 Lovastatin lovastatin Lupin Pharmaceuticals, Inc. ANDA Current 68645-566 Lovastatin lovastatin Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-566 Lovastatin lovastatin Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-566 Lovastatin lovastatin Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-566 Lovastatin lovastatin Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-567 Lovastatin lovastatin Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-567 Lovastatin lovastatin Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-567 Lovastatin lovastatin Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-567 Lovastatin lovastatin Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-576 Lovastatin Lovastatin Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-576 Lovastatin Lovastatin Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-576 Lovastatin Lovastatin Legacy Pharmaceutical Packaging, LLC ANDA Current 68788-6876 Lovastatin lovastatin Preferred Pharmaceuticals Inc. ANDA Current 68788-7002 Lovastatin lovastatin Preferred Pharmaceuticals, Inc. ANDA Current 68788-8232 Lovastatin lovastatin Preferred Pharmaceuticals, Inc. ANDA Current 68788-8287 Lovastatin lovastatin Preferred Pharmaceuticals, Inc. ANDA Current 70518-0706 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-0706 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-0706 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-0706 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-0706 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-2009 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-2009 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-2009 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-2009 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-2009 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-2727 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-2727 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-2727 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70518-2727 Lovastatin lovastatin REMEDYREPACK INC. ANDA Current 70934-547 Lovastatin lovastatin Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 71205-199 Lovastatin lovastatin Proficient Rx LP ANDA Current 71205-199 Lovastatin lovastatin Proficient Rx LP ANDA Current 71205-199 Lovastatin lovastatin Proficient Rx LP ANDA Current 71205-199 Lovastatin lovastatin Proficient Rx LP ANDA Current 71335-0819 Lovastatin lovastatin Bryant Ranch Prepack ANDA Current 71335-0819 Lovastatin lovastatin Bryant Ranch Prepack ANDA Current 71335-0882 Lovastatin lovastatin Bryant Ranch Prepack ANDA Current