Application 078296

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOVASTATINLOVASTATINTABLET;ORAL10MGNoNo
002LOVASTATINLOVASTATINTABLET;ORAL20MGNoNo
003LOVASTATINLOVASTATINTABLET;ORAL40MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078296-001LOVASTATINLOVASTATIN10MGTABLET / ORALAB2008-03-14
A078296-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2007-11-01
A078296-003LOVASTATINLOVASTATIN40MGTABLET / ORALAB2007-11-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078296-001AB
A078296-002AB
A078296-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-0184e616aacf4f…
2026-09-14 22:38:342026-08A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-0184e616aacf4f…
2026-08-18 06:07:402026-07A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078296-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078296-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078296-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078296-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078296-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078296-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078296-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078296-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078296-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078296-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078296-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078296-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078296-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078296-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078296-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078296-001AB1301d65b070ca…

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 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LovastatinLOVASTATINPD-Rx Pharmaceuticals, Inc.e75b5808-ec66-4da7-90bc-e53611aa1b342026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.397949f9-ce60-424f-9902-90e65a34f4de2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
ndc (product): 68788-8232
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.22c9f2d8-7bcd-4415-bbc8-5057200339662026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINBryant Ranch Prepack030c0f79-6bb5-4876-bf8e-b7a25b25dd382026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
ndc (product): 71335-0882
LovastatinLOVASTATINBryant Ranch Prepackf5f265a6-2aa5-4205-9159-40133ae93ac02026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
ndc (product): 71335-0819
LovastatinLOVASTATINBluePoint Laboratories7b86160d-74a9-4774-b5b3-5641e686991f2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINREMEDYREPACK INC.ff040b3c-6790-40d7-bd64-a4073b4a20452026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
ndc (product): 70518-2009
LovastatinLOVASTATINLupin Pharmaceuticals, Inc.df7ddf4f-d569-431e-81f1-9129d70431502026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
ndc (product): 68180-468
ndc (product): 68180-467
ndc (product): 68180-469
LovastatinLOVASTATINLegacy Pharmaceutical Packaging, LLCa4f02fa1-3281-46fa-bd52-323e2644b6f82026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
ndc (product): 68645-567
ndc (product): 68645-566
LovastatinLOVASTATINNorthwind Health Company, LLCf308fe1c-23a9-6409-e053-2995a90abfd92026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNorthwind Health Company, LLCca59cbd4-a4c1-aebe-e053-2a95a90ae9682026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNorthwind Health Company, LLCf99e0b4c-e757-4ccd-e053-6294a90ab7222026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINA-S Medication Solutions06b8c398-ce2e-42c1-b1a8-73cc59a080db2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINBoswell Pharmacy Services LLC d/b/a BPS Wholesale2eeb34ac-f973-e7d9-e063-6294a90a076e2025-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNuCare Pharmaceuticals, Inc.50217921-97a7-6ff2-e054-00144ff88e882025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINA-S Medication Solutions02aae38d-ee9d-4c09-a155-b69f221ed3e92024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNCS HealthCare of KY, LLC dba Vangard Labs3af47e72-082d-42ad-bde0-294f8101b45c2024-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNuCare Pharmaceuticals,Inc.19b2bb87-1dc7-cd72-e063-6394a90a0f732024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNuCare Pharmaceuticals,Inc.1ac7ffb9-860a-fbb6-e063-6294a90a590f2024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINProficient Rx LP2b53ab6a-5770-4fd7-9aa1-f4273d4bdaeb2022-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-467LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68180-467LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68180-467LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68180-467LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68180-468LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68180-468LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68180-468LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68180-468LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68180-469LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68180-469LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68180-469LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68180-469LovastatinlovastatinLupin Pharmaceuticals, Inc.ANDACurrent
68645-566LovastatinlovastatinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-566LovastatinlovastatinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-566LovastatinlovastatinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-566LovastatinlovastatinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-567LovastatinlovastatinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-567LovastatinlovastatinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-567LovastatinlovastatinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-567LovastatinlovastatinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-576LovastatinLovastatinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-576LovastatinLovastatinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-576LovastatinLovastatinLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-6876LovastatinlovastatinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7002LovastatinlovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8232LovastatinlovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8287LovastatinlovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0706LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-0706LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-0706LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-0706LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-0706LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-2009LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-2009LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-2009LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-2009LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-2009LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-2727LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-2727LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-2727LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70518-2727LovastatinlovastatinREMEDYREPACK INC.ANDACurrent
70934-547LovastatinlovastatinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-199LovastatinlovastatinProficient Rx LPANDACurrent
71205-199LovastatinlovastatinProficient Rx LPANDACurrent
71205-199LovastatinlovastatinProficient Rx LPANDACurrent
71205-199LovastatinlovastatinProficient Rx LPANDACurrent
71335-0819LovastatinlovastatinBryant Ranch PrepackANDACurrent
71335-0819LovastatinlovastatinBryant Ranch PrepackANDACurrent
71335-0882LovastatinlovastatinBryant Ranch PrepackANDACurrent