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 3 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 2019-12-13 00:20 UTC 2019-12 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N009268-003 CHOLEDYL 100MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N009268-007 CHOLEDYL 200MG TABLET, DELAYED RELEASE / ORAL Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N009268-011 CHOLEDYL 50MG/5ML SYRUP / ORAL Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N009268-012 CHOLEDYL 100MG/5ML SOLUTION / ORAL 1984-11-27 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.