FDA.reportPublic FDA data

Application 020702

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIPITORATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASEYesNo
002LIPITORATORVASTATIN CALCIUMTABLET;ORALEQ 20MG BASEYesNo
003LIPITORATORVASTATIN CALCIUMTABLET;ORALEQ 40MG BASEYesNo
004LIPITORATORVASTATIN CALCIUMTABLET;ORALEQ 80MG BASEYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020702-001LIPITORATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALABRLD1996-12-17
N020702-002LIPITORATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALABRLD1996-12-17
N020702-003LIPITORATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALABRLD1996-12-17
N020702-004LIPITORATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALABRLD, RS2000-04-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N020702-001AB
N020702-002AB
N020702-003AB
N020702-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-0784e616aacf4f…
2026-08-18 06:07:402026-07N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-075bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020702-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020702-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020702-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N020702-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N020702-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020702-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020702-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-004AB15bbf6a4d5a75…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N020702-001M-2042020-06-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020702-002M-2042020-06-2374a2ff9319b5…
2020-12-22 03:56 UTC2020-12N020702-001M-2042020-06-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020702-002M-2042020-06-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020702-001M-2042020-06-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020702-002M-2042020-06-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020702-001M-2042020-06-233f01610625f2…
2019-12-14 00:12 UTC2019-12N020702-002M-2042020-06-233f01610625f2…
2019-09-15 20:21 UTC2019-09N020702-001M-2042020-06-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N020702-002M-2042020-06-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N020702-001M-2042020-06-23ea99ee380514…
2019-07-19 19:46 UTC2019-07N020702-002M-2042020-06-23ea99ee380514…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LipitorATORVASTATIN CALCIUMViatris Specialty LLCa60cc18b-0631-4cf0-b021-9f52224ece652024-04-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 020702
application number: NDA020702

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 · 154 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55289-800Lipitoratorvastatin calcium trihydratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-800Lipitoratorvastatin calcium trihydratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-800Lipitoratorvastatin calcium trihydratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-800Lipitoratorvastatin calcium trihydratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-800Lipitoratorvastatin calcium trihydratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-800Lipitoratorvastatin calcium trihydratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-861Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-861Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-861Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-861Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-861Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-861Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-870Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-870Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-870Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-870Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-870Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-870Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-870Lipitoratorvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
59762-0155ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0155ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0155ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0155ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0155ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0156ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0156ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0156ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0156ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0156ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0157ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0157ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0157ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0157ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0157ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0158ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0158ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0158ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0158ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0158ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGreenstone LLCNDA AUTHORIZED GENERICCurrent
63629-1446Lipitoratorvastatin calciumBryant Ranch PrepackNDACurrent
63629-1446Lipitoratorvastatin calciumBryant Ranch PrepackNDACurrent
63629-1446LipitorATORVASTATIN CALCIUMBryant Ranch PrepackNDACurrent
63629-1447Lipitoratorvastatin calciumBryant Ranch PrepackNDACurrent
63629-4849ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6308ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6308ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6352ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6352ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6454ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6454ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6633Lipitoratorvastatin calciumBryant Ranch PrepackNDACurrent
63629-6633Lipitoratorvastatin calciumBryant Ranch PrepackNDACurrent
63629-6634ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6634ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6768Lipitoratorvastatin calciumBryant Ranch PrepackNDACurrent
63629-6768Lipitoratorvastatin calciumBryant Ranch PrepackNDACurrent
63629-6776Lipitoratorvastatin calciumBryant Ranch PrepackNDACurrent
63629-6776Lipitoratorvastatin calciumBryant Ranch PrepackNDACurrent
68645-458ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-458ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-458ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-459ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-459ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-459ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-460ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-460ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-460ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-461ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-461ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-461ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-482ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
68645-483ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLegacy Pharmaceutical Packaging, LLCNDA AUTHORIZED GENERICCurrent
70518-0036Lipitoratorvastatin calciumREMEDYREPACK INC.NDACurrent
70518-3326ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78046SUPPL 2024-04-03
78041SUPPL 2024-04-03
72893SUPPL2022-12-15
72831SUPPL2022-12-09
65260SUPPL2020-11-18
65234SUPPL2020-11-16
64723SUPPL2020-09-29
64699SUPPL2020-09-28
61105SUPPL2019-11-29
61091SUPPL2019-11-29
58348SUPPL2019-04-22
58330SUPPL2019-04-15
55225SUPPL2018-08-20
55168SUPPL2018-08-13
48846SUPPL2017-06-27
48845SUPPL2017-06-27
48840SUPPL2017-06-27
48839SUPPL2017-06-27
35179SUPPL2015-03-17
3135SUPPL2015-03-13
35178SUPPL2014-05-28
25577SUPPL2014-05-22
20856SUPPL2013-08-06
3134SUPPL2012-11-05
3133SUPPL2012-11-05
35177SUPPL2012-11-02
13249SUPPL2012-11-02
41591SUPPL2012-03-30
35176SUPPL2012-02-28
25576SUPPL2012-02-28
3132SUPPL2010-11-05
20841ORIG2010-03-16
35174SUPPL2009-06-22
35175SUPPL2009-04-03
25575SUPPL2009-04-01
41590SUPPL2008-08-01
20855SUPPL2008-08-01
41587SUPPL2008-07-31
20850SUPPL2008-02-19
20854SUPPL2007-12-06
20853SUPPL2007-12-06
20852SUPPL2007-12-06
41586SUPPL2007-11-19
41584SUPPL2007-11-19
41583SUPPL2007-11-19
20847SUPPL2007-11-19
20846SUPPL2007-11-19
20845SUPPL2007-11-19
25574SUPPL2007-10-04
41589SUPPL2007-09-26
41588SUPPL2007-09-26
35173SUPPL2007-09-26
41582SUPPL2007-07-06
20849SUPPL2007-07-06
25572SUPPL2007-03-07
13248SUPPL2007-03-07
25573SUPPL2007-01-25
35172SUPPL2007-01-18
35171SUPPL2006-08-09
3130SUPPL2006-08-09
23061SUPPL2006-06-28
3131SUPPL2006-06-27
3128SUPPL2005-10-20
3129SUPPL2005-10-14
35170SUPPL2005-09-30
25571SUPPL2004-08-02
13245SUPPL2004-06-08
3126SUPPL2004-06-08
43563SUPPL2004-05-27
25568SUPPL2004-05-26
13247SUPPL2003-10-10
25570SUPPL2003-10-09
3127SUPPL2003-06-08
13246SUPPL2003-05-29
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