Application 206015

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMTABLET;ORALEQ 1MG BASENoNo
002PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMTABLET;ORALEQ 2MG BASENoNo
003PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMTABLET;ORALEQ 4MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A206015-001PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2016-12-20
A206015-002PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2016-12-20
A206015-003PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2016-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206015-001AB
A206015-002AB
A206015-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206015-001PITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2016-12-20a50c72e98297…
2026-08-01 22:54:322026-06A206015-002PITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2016-12-20a50c72e98297…
2026-08-01 22:54:322026-06A206015-003PITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2016-12-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206015-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206015-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206015-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PitavastatinPITAVASTATINAurobindo Pharma Limiteda52401eb-a822-475b-a40d-7b8acde2ae1a2024-04-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206015
application number: ANDA206015

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47078ORIG2017-01-31
46484ORIG2016-12-22