FDA.reportPublic FDA data

Application 075636

Type
ANDA
Sponsor
SANDOZ

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 1.

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
A075636-001LOVASTATINLOVASTATIN10MGTABLET / ORALAB2001-12-17
A075636-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2001-12-17
A075636-003LOVASTATINLOVASTATIN40MGTABLET / ORALAB2001-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075636-001AB
A075636-002AB
A075636-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-17a50c72e98297…
2026-08-01 22:54:322026-06A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-17a50c72e98297…
2026-08-01 22:54:322026-06A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075636-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075636-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075636-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LovastatinLOVASTATINREMEDYREPACK INC.9438d8a0-ca5b-4676-aab9-d0241ccff6c92026-07-23Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINPD-Rx Pharmaceuticals, Inc.e75b5808-ec66-4da7-90bc-e53611aa1b342026-06-12Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINPreferred Pharmaceuticals Inc.56680dfa-abe6-4587-b222-364315fd78f42026-06-03Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.397949f9-ce60-424f-9902-90e65a34f4de2026-06-03Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.22c9f2d8-7bcd-4415-bbc8-5057200339662026-06-03Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.ea4df37b-21e9-4dc3-83af-1be1b50bfdc92026-06-03Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINBryant Ranch Prepack030c0f79-6bb5-4876-bf8e-b7a25b25dd382026-05-29Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINBryant Ranch Prepackf5f265a6-2aa5-4205-9159-40133ae93ac02026-05-28Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINBluePoint Laboratories7b86160d-74a9-4774-b5b3-5641e686991f2026-05-27Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINREMEDYREPACK INC.ff040b3c-6790-40d7-bd64-a4073b4a20452026-05-21Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINLupin Pharmaceuticals, Inc.df7ddf4f-d569-431e-81f1-9129d70431502026-05-06Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINREMEDYREPACK INC.a902a95f-072a-4487-99a9-109a93f8b23c2026-04-03Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINLegacy Pharmaceutical Packaging, LLCa4f02fa1-3281-46fa-bd52-323e2644b6f82026-03-11Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINBryant Ranch Prepack7fd9d5c7-8025-4049-8b5b-ae3d22db507f2026-03-09Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINNorthwind Health Company, LLCf308fe1c-23a9-6409-e053-2995a90abfd92026-01-01Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINNorthwind Health Company, LLCca59cbd4-a4c1-aebe-e053-2a95a90ae9682026-01-01Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINNorthwind Health Company, LLCdb47ddae-c574-427f-e053-2a95a90aae482026-01-01Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINNorthwind Health Company, LLCf99e0b4c-e757-4ccd-e053-6294a90ab7222026-01-01Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINGolden State Medical Supply, Inc.91332c54-1a27-4e6b-e053-2a95a90a42cd2025-12-15Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN
LovastatinLOVASTATINA-S Medication Solutions06b8c398-ce2e-42c1-b1a8-73cc59a080db2025-10-15Warnings, Adverse reactionsName fallback
brand name: Lovastatin
generic name: LOVASTATIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0070LovastatinLovastatinEon Labs, Inc.ANDACurrent
0185-0070LovastatinLovastatinEon Labs, Inc.ANDACurrent
0185-0072LovastatinLovastatinEon Labs, Inc.ANDACurrent
0185-0072LovastatinLovastatinEon Labs, Inc.ANDACurrent
0185-0074LovastatinLovastatinEon Labs, Inc.ANDACurrent
0185-0074LovastatinLovastatinEon Labs, Inc.ANDACurrent
50090-2278LovastatinLovastatinA-S Medication SolutionsANDACurrent
61919-676LOVASTATINLOVASTATINDIRECT RXANDACurrent
61919-676LOVASTATINLOVASTATINDIRECT RXANDACurrent
66267-555LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-555LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
67046-450LovastatinLovastatinContract Pharmacy Services-PAANDACurrent
67046-451LovastatinLovastatinContract Pharmacy Services-PAANDACurrent
67544-106LovastatinLovastatinAphena Pharma Solutions -ANDACurrent
67544-225LovastatinLovastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-225LovastatinLovastatinAphena Pharma Solutions -ANDACurrent
67544-245LovastatinLovastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-245LovastatinLovastatinAphena Pharma Solutions -ANDACurrent
68001-214LovastatinLovastatinBluePoint LaboratoriesANDACurrent
68001-224LovastatinLovastatinBluePoint LaboratoriesANDACurrent
68071-1973LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3397LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22492ORIG2005-07-22