Application 075991

Type
ANDA
Sponsor
CARLSBAD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOVASTATINLOVASTATINTABLET;ORAL10MGNoNo
002LOVASTATINLOVASTATINTABLET;ORAL20MGNoNo
003LOVASTATINLOVASTATINTABLET;ORAL40MGNoYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075991-001LOVASTATINLOVASTATIN10MGTABLET / ORALAB2002-06-05
A075991-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2002-06-05
A075991-003LOVASTATINLOVASTATIN40MGTABLET / ORALABRS2002-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075991-001AB
A075991-002AB
A075991-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05c2088c7a36db…
2026-10-15 13:18:302026-09A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05c2088c7a36db…
2026-10-15 13:18:302026-09A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05c2088c7a36db…
2026-09-14 22:38:342026-08A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-0584e616aacf4f…
2026-08-18 06:07:402026-07A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-0579d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A075991-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A075991-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A075991-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A075991-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075991-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075991-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A075991-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075991-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075991-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075991-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075991-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075991-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075991-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075991-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075991-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075991-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075991-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075991-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075991-001AB179d66fd596c7…

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 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LovastatinLOVASTATINBryant Ranch Prepacka623c1da-e94e-41be-900c-9e74376d36c82024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
ndc (product): 63629-1191
LovastatinLOVASTATINNuCare Pharmaceuticals, Inc.4aa44b69-2946-2fb1-e054-00144ff8d46c2024-07-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
ndc (product): 68071-3127
LovastatinLOVASTATINNuCare Pharmaceuticals,Inc.8ccb2a86-cd02-4162-e053-2995a90abe0e2024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
ndc (product): 68071-4955
LovastatinLOVASTATINAphena Pharma Solutions - Tennessee, LLC0399c35c-513d-48e6-aa20-e8434e3b18d52024-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINProficient Rx LPda9c25c1-f65c-4dc6-8e13-f727c50fd4e42022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINProficient Rx LP25efd38a-1495-4824-9137-a3429bc471bd2022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
ndc (product): 71205-994
ndc (product): 71205-993
ndc (product): 71205-992
LovastatinLOVASTATINProficient Rx LP4b512c0b-b2f6-4a16-bee6-7669195497ad2021-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINProficient Rx LPc2b1b926-def3-4411-9aed-395b969028fe2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991

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 · 160 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-1178LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-1178LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-1178LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-1191LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-1191LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-1191LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-1464LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-1464LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-3583LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-3583LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-3583LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-7687LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-7687LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-7687LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-7688LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-7688LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-7688LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-8091LovastatinLovastatinBryant Ranch PrepackANDACurrent
63629-8091LovastatinLovastatinBryant Ranch PrepackANDACurrent
66267-506LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-506LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-506LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-561LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-561LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
66336-602LovastatinLovastatinDispensing Solutions, Inc.ANDACurrent
68071-3127LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3127LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3127LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4955LovastatinLovastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4955LovastatinLovastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7056LovastatinLovastatinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7056LovastatinLovastatinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7056LovastatinLovastatinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7056LovastatinLovastatinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7056LovastatinLovastatinPreferred Pharmaceuticals Inc.ANDACurrent
68788-9667LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9667LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9667LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9667LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9667LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9668LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9668LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9668LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9668LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9668LovastatinLovastatinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0113LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-0113LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-0113LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-0113LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-0113LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-0113LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-0113LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-0194LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-0194LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-0194LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-0194LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-0194LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-2425LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70934-415LovastatinLovastatinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-415LovastatinLovastatinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-658LovastatinLovastatinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-992LovastatinLovastatinProficient Rx LPANDACurrent
71205-992LovastatinLovastatinProficient Rx LPANDACurrent
71205-992LovastatinLovastatinProficient Rx LPANDACurrent
71205-992LovastatinLovastatinProficient Rx LPANDACurrent
71205-993LovastatinLovastatinProficient Rx LPANDACurrent
71205-993LovastatinLovastatinProficient Rx LPANDACurrent
71205-993LovastatinLovastatinProficient Rx LPANDACurrent
71205-993LovastatinLovastatinProficient Rx LPANDACurrent
71205-994LovastatinLovastatinProficient Rx LPANDACurrent
71205-994LovastatinLovastatinProficient Rx LPANDACurrent
71205-994LovastatinLovastatinProficient Rx LPANDACurrent
71205-994LovastatinLovastatinProficient Rx LPANDACurrent
71335-0045LovastatinLovastatinBryant Ranch PrepackANDACurrent
71335-0045LovastatinLovastatinBryant Ranch PrepackANDACurrent
71335-0045LovastatinLovastatinBryant Ranch PrepackANDACurrent
71335-0045LovastatinLovastatinBryant Ranch PrepackANDACurrent
71335-1617LovastatinLovastatinBryant Ranch PrepackANDACurrent
71335-1633LovastatinLovastatinBryant Ranch PrepackANDACurrent
71335-1633LovastatinLovastatinBryant Ranch PrepackANDACurrent