FDA.reportPublic FDA data

Application 214862

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OBETICHOLIC ACIDOBETICHOLIC ACIDTABLET;ORAL5MGNoNo
002OBETICHOLIC ACIDOBETICHOLIC ACIDTABLET; ORAL10mgNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214862-001OBETICHOLIC ACIDOBETICHOLIC ACID5MGTABLET / ORAL2023-05-30
A214862-002OBETICHOLIC ACIDOBETICHOLIC ACID10MGTABLET / ORAL2023-05-30

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 2 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214862-001OBETICHOLIC ACID5MGTABLET / ORAL2023-05-309b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214862-002OBETICHOLIC ACID10MGTABLET / ORAL2023-05-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214862-001OBETICHOLIC ACID5MGTABLET / ORALAB2023-05-30a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214862-002OBETICHOLIC ACID10MGTABLET / ORALAB2023-05-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214862-001OBETICHOLIC ACID5MGTABLET / ORALAB2023-05-303f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214862-002OBETICHOLIC ACID10MGTABLET / ORALAB2023-05-303f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214862-001OBETICHOLIC ACID5MGTABLET / ORAL2023-05-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214862-002OBETICHOLIC ACID10MGTABLET / ORAL2023-05-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214862-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214862-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214862-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214862-002AB13f0d92c62455…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74527ORIG 2023-06-16