Home Applications 009268 Application 009268
Type NDA
Sponsor PARKE DAVIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 003 CHOLEDYL OXTRIPHYLLINE TABLET, DELAYED RELEASE;ORAL 100MG No No 007 CHOLEDYL OXTRIPHYLLINE TABLET, DELAYED RELEASE;ORAL 200MG No No 011 CHOLEDYL OXTRIPHYLLINE SYRUP;ORAL 50MG/5ML No No 012 CHOLEDYL OXTRIPHYLLINE SOLUTION;ORAL 100MG/5ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N009268-003 CHOLEDYL OXTRIPHYLLINE 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 N009268-007 CHOLEDYL OXTRIPHYLLINE 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 N009268-011 CHOLEDYL OXTRIPHYLLINE 50MG/5ML SYRUP / ORAL Approved before 1982 N009268-012 CHOLEDYL OXTRIPHYLLINE 100MG/5ML SOLUTION / ORAL 1984-11-27
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 5 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.