Application 075828

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

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 42.

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
A075828-001LOVASTATINLOVASTATIN10MGTABLET / ORALAB2001-12-17
A075828-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2001-12-17
A075828-003LOVASTATINLOVASTATIN40MGTABLET / 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
A075828-001AB
A075828-002AB
A075828-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075828-002LOVASTATIN20MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075828-003LOVASTATIN40MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075828-001LOVASTATIN10MGTABLET / ORALAB2001-12-171e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075828-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075828-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075828-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075828-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075828-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075828-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075828-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075828-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075828-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075828-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075828-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075828-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075828-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075828-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075828-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075828-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075828-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075828-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075828-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075828-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075828-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075828-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075828-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075828-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075828-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075828-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075828-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075828-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075828-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075828-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075828-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075828-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075828-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075828-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075828-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075828-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075828-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075828-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075828-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075828-001AB11e350fbaab3a…

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 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 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-5589LovastatinLovastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6551LovastatinLovastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6590LovastatinLovastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7674LovastatinLovastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7679LovastatinLovastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7685LovastatinLovastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7690LovastatinLovastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-246LovastatinLovastatinBlenheim Pharmacal, Inc.ANDACurrent
35356-885LovastatinLovastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
43353-995LovastatinLovastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
45963-633LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-633LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-633LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-633LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-633LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-634LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-634LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-634LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-634LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-634LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-635LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-635LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-635LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-635LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
45963-635LovastatinLovastatinActavis Pharma, Inc.ANDACurrent
49999-293LovastatinLovastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-293LovastatinLovastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
51655-013LovastatinLovastatinNorthwind Pharmaceuticals, LLCANDACurrent
60429-400LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-400LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-400LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-400LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-400LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-400LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-401LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-401LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-401LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-401LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-401LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-402LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-402LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-402LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-402LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
60429-402LovastatinLovastatinGolden State Medical Supply, Inc.ANDACurrent
63739-281LovastatinLovastatinMcKesson CorporationANDACurrent
63739-282LovastatinLovastatinMcKesson CorporationANDACurrent
68071-3108LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68084-559LovastatinLovastatinAmerican Health PackagingANDACurrent
68788-0074LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0926LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-2634LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9180LovastatinLovastatinPreferred Pharmaceuticals, IncANDACurrent
68788-9181LovastatinLovastatinPreferred Pharmaceuticals, IncANDACurrent
68788-9182LovastatinLovastatinPreferred Pharmaceuticals, IncANDACurrent
70518-0206LovastatinLovastatinREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22508ORIG2005-07-22