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 1.

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020702-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020702-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020702-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020702-004AB1d06236e962d9…

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

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 154 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0179-0141ATORVASTATIN CALCIUMATORVASTATIN CALCIUMKAISER FOUNDATION HOSPITALSNDA AUTHORIZED GENERICCurrent
0179-0214ATORVASTATIN CALCIUMATORVASTATIN CALCIUMKAISER FOUNDATION HOSPITALSNDA AUTHORIZED GENERICCurrent
0179-0215ATORVASTATIN CALCIUMATORVASTATIN CALCIUMKAISER FOUNDATION HOSPITALSNDA AUTHORIZED GENERICCurrent
0179-0216ATORVASTATIN CALCIUMATORVASTATIN CALCIUMKAISER FOUNDATION HOSPITALSNDA AUTHORIZED GENERICCurrent
21695-255Lipitoratorvastatin calciumRebel Distributors CorpNDACurrent
42254-019ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRebel Distributors CorpNDA AUTHORIZED GENERICCurrent
42254-261ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRebel Distributors CorpNDA AUTHORIZED GENERICCurrent
42254-267ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRebel Distributors CorpNDA AUTHORIZED GENERICCurrent
42254-307ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRebel Distributors CorpNDA AUTHORIZED GENERICCurrent
43353-120ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-120ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-826ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-826ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-827ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-827ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-892ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-892ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
49299-1090LIPITORatorvastatin calciumPHARMAKON, LLCNDACurrent
49299-1091LIPITORatorvastatin calciumPHARMAKON, LLCNDACurrent
49299-1092LIPITORatorvastatin calciumPHARMAKON, LLCNDACurrent
49299-1093LIPITORatorvastatin calciumPHARMAKON, LLCNDACurrent
51655-880Atorvastatin CalciumAtorvastatin CalciumNorthwind PharmaceuticalsANDACurrent
53808-0951ATORVASTATIN CALCIUMATORVASTATIN CALCIUMState of Florida DOH Central PharmacyNDA AUTHORIZED GENERICCurrent
55289-800Lipitoratorvastatin calcium trihydratePD-Rx Pharmaceuticals, Inc.NDACurrent

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
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