FDA.reportPublic FDA data

Application 021540

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 5MG BASE;EQ 10MG BASEYesNo
002CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 5MG BASE;EQ 20MG BASEYesNo
003CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 5MG BASE;EQ 40MG BASEYesNo
004CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 5MG BASE;EQ 80MG BASEYesNo
005CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASE;EQ 10MG BASEYesNo
006CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASE;EQ 20MG BASEYesNo
007CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASE;EQ 40MG BASEYesNo
008CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASE;EQ 80MG BASEYesYes
009CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 2.5MG BASE;EQ 10MG BASEYesNo
010CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 2.5MG BASE;EQ 20MG BASEYesNo
011CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 2.5MG BASE;EQ 40MG BASEYesNo

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

Orange Book products#

Current product rows page 1 of 1 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021540-001CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-30
N021540-002CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-30
N021540-003CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-30
N021540-004CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 80MG BASETABLET / ORALABRLD2004-01-30
N021540-005CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-30
N021540-006CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-30
N021540-007CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-30
N021540-008CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 80MG BASETABLET / ORALABRLD, RS2004-01-30
N021540-009CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-07-29
N021540-010CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-07-29
N021540-011CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 11 matching rows.

Application-product, TE code table
Application-productTE code
N021540-001AB
N021540-002AB
N021540-003AB
N021540-004AB
N021540-005AB
N021540-006AB
N021540-007AB
N021540-008AB
N021540-009AB
N021540-010AB
N021540-011AB

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 12 · 473 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021540-001CADUETEQ 5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N021540-002CADUETEQ 5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N021540-003CADUETEQ 5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N021540-004CADUETEQ 5MG BASE;EQ 80MG BASETABLET / ORALABRLD2004-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N021540-005CADUETEQ 10MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N021540-006CADUETEQ 10MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N021540-007CADUETEQ 10MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N021540-008CADUETEQ 10MG BASE;EQ 80MG BASETABLET / ORALABRLD, RS2004-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N021540-009CADUETEQ 2.5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N021540-010CADUETEQ 2.5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N021540-011CADUETEQ 2.5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-07-2984e616aacf4f…
2026-08-18 06:07:402026-07N021540-001CADUETEQ 5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-002CADUETEQ 5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-003CADUETEQ 5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-004CADUETEQ 5MG BASE;EQ 80MG BASETABLET / ORALABRLD2004-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-005CADUETEQ 10MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-006CADUETEQ 10MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-007CADUETEQ 10MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-008CADUETEQ 10MG BASE;EQ 80MG BASETABLET / ORALABRLD, RS2004-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-009CADUETEQ 2.5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-010CADUETEQ 2.5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-011CADUETEQ 2.5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021540-001CADUETEQ 5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-002CADUETEQ 5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-003CADUETEQ 5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-004CADUETEQ 5MG BASE;EQ 80MG BASETABLET / ORALABRLD2004-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-005CADUETEQ 10MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-006CADUETEQ 10MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-007CADUETEQ 10MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-008CADUETEQ 10MG BASE;EQ 80MG BASETABLET / ORALABRLD, RS2004-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-009CADUETEQ 2.5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-010CADUETEQ 2.5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-011CADUETEQ 2.5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-001CADUETEQ 5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-002CADUETEQ 5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-003CADUETEQ 5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-004CADUETEQ 5MG BASE;EQ 80MG BASETABLET / ORALABRLD2004-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-005CADUETEQ 10MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-006CADUETEQ 10MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-007CADUETEQ 10MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-3031067a03dcf5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 12 · 473 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021540-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N021540-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N021540-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N021540-004AB184e616aacf4f…
2026-09-14 22:38:342026-08N021540-005AB184e616aacf4f…
2026-09-14 22:38:342026-08N021540-006AB184e616aacf4f…
2026-09-14 22:38:342026-08N021540-007AB184e616aacf4f…
2026-09-14 22:38:342026-08N021540-008AB184e616aacf4f…
2026-09-14 22:38:342026-08N021540-009AB184e616aacf4f…
2026-09-14 22:38:342026-08N021540-010AB184e616aacf4f…
2026-09-14 22:38:342026-08N021540-011AB184e616aacf4f…
2026-08-18 06:07:402026-07N021540-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-008AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-009AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-010AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021540-011AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021540-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-008AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-009AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-010AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021540-011AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021540-007AB131067a03dcf5…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CaduetAMLODIPINE AND ATORVASTATINPfizer Laboratories Div Pfizer Inc6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b62026-06-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 021540
application number: NDA021540
ndc (product): 0069-6323
ndc (product): 0069-6565
ndc (product): 0069-7654
ndc (product): 0069-7810
ndc (product): 0069-6747
ndc (product): 0069-7232
ndc (product): 0069-6180
ndc (product): 0069-7476
CaduetAMLODIPINE AND ATORVASTATINViatris Specialty LLC164394b3-d7ba-4bbf-b64b-e2dd15735ea82026-06-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 021540
application number: NDA021540
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINPrasco Laboratories14124e56-77ba-426d-8f5a-dbe42eda1a202026-05-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 021540
application number: NDA021540

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 3 · 174 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-2960Caduetamlodipine besylate and atorvastatin calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-2960Caduetamlodipine besylate and atorvastatin calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-2960Caduetamlodipine besylate and atorvastatin calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-2970Caduetamlodipine besylate and atorvastatin calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-2970Caduetamlodipine besylate and atorvastatin calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-2970Caduetamlodipine besylate and atorvastatin calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-2980Caduetamlodipine besylate and atorvastatin calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-2980Caduetamlodipine besylate and atorvastatin calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-2980Caduetamlodipine besylate and atorvastatin calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-6180Caduetamlodipine and atorvastatinPfizer Laboratories Div Pfizer IncNDACurrent
0069-6323Caduetamlodipine and atorvastatinPfizer Laboratories Div Pfizer IncNDACurrent
0069-6565Caduetamlodipine and atorvastatinPfizer Laboratories Div Pfizer IncNDACurrent
0069-6747Caduetamlodipine and atorvastatinPfizer Laboratories Div Pfizer IncNDACurrent
0069-7232Caduetamlodipine and atorvastatinPfizer Laboratories Div Pfizer IncNDACurrent
0069-7476Caduetamlodipine and atorvastatinPfizer Laboratories Div Pfizer IncNDACurrent
0069-7654Caduetamlodipine and atorvastatinPfizer Laboratories Div Pfizer IncNDACurrent
0069-7810Caduetamlodipine and atorvastatinPfizer Laboratories Div Pfizer IncNDACurrent
0069-7810Caduetamlodipine and atorvastatinPfizer Laboratories Div Pfizer IncNDACurrent
59762-6710Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6710Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6710Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6710Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6710Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6711Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6711Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6711Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6711Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6711Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6711Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6712Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6712Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6712Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6712Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6712Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6712Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6720Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6720Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6720Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6720Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6720Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6720Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6721Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6721Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6721Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6721Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6721Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6721Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6722Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6722Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6722Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6722Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6722Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6722Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6723Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6723Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6723Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6723Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6723Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6723Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6730Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6730Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6730Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6730Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6730Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6730Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6731Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6731Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6731Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6731Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
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59762-6732Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
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59762-6732Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6732Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6732Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
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59762-6733Amlodipine besylate and Atorvastatin calciumamlodipine besylate and atorvastatin calciumGreenstone LLCNDA AUTHORIZED GENERICCurrent
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Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80148SUPPL 2024-11-05
78524SUPPL 2024-05-21
78515SUPPL 2024-05-20
66207SUPPL2021-02-12
65950SUPPL2021-01-21
65869SUPPL2021-01-08
65599SUPPL2020-12-16
64743SUPPL2020-09-29
64725SUPPL2020-09-29
61384SUPPL2019-12-23
61343SUPPL2019-12-19
58679SUPPL2019-05-14
58658SUPPL2019-05-13
55489SUPPL2018-10-29
55488SUPPL2018-10-29
55526SUPPL2018-09-19
55525SUPPL2018-09-19
54364SUPPL2018-05-29
54357SUPPL2018-05-29
50260SUPPL2017-11-02
48847SUPPL2017-06-27
48841SUPPL2017-06-27
15733SUPPL2015-03-27
15732SUPPL2015-03-27
5686SUPPL2015-03-25
28074SUPPL2015-02-19
15731SUPPL2014-05-28
28073SUPPL2014-05-27
37191SUPPL2013-11-13
15730SUPPL2013-11-13
5685SUPPL2013-11-12
5684SUPPL2013-11-12
5683SUPPL2012-11-06
37190SUPPL2012-11-02
37189SUPPL2012-07-30
37188SUPPL2012-07-30
28072SUPPL2012-07-30
28071SUPPL2012-07-30
28070SUPPL2010-02-23
15729SUPPL2010-02-23
28069SUPPL2009-11-24
15728SUPPL2009-07-23
28068SUPPL2008-06-02
37187SUPPL2007-09-26
37186SUPPL2007-09-26
28067SUPPL2007-09-25
28066SUPPL2007-09-25
28064SUPPL2006-09-18
15727SUPPL2006-08-29
28065SUPPL2006-04-20
37185SUPPL2006-04-14
37184SUPPL2004-09-29
28063SUPPL2004-09-29
21726ORIG2004-08-05
37183ORIG2004-02-03
28062ORIG2004-02-03