Application 220276

Type
ANDA
Sponsor
TEVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASENoNo
002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 20MG BASENoNo
003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 40MG BASENoNo
004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 80MG BASENoNo

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
A220276-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2025-11-13
A220276-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2025-11-13
A220276-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2025-11-13
A220276-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2025-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220276-001AB
A220276-002AB
A220276-003AB
A220276-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A220276-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A220276-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A220276-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A220276-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2025-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220276-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2025-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220276-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2025-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220276-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2025-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220276-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2025-11-1331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220276-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220276-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220276-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220276-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2025-11-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A220276-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A220276-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A220276-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A220276-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220276-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220276-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220276-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220276-004AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220276-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220276-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220276-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220276-004AB1a50c72e98297…

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
Atorvastatin CalciumATORVASTATIN CALCIUMTeva Pharmaceuticals, Inc.d3497ad6-b549-4144-b57f-b2088ad80b092025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220276
application number: ANDA220276