Home Applications 021183 Application 021183
Type NDA
Sponsor BRISTOL MYERS SQUIBB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VIDEX EC DIDANOSINE CAPSULE, DELAYED REL PELLETS;ORAL 125MG Yes No 002 VIDEX EC DIDANOSINE CAPSULE, DELAYED REL PELLETS;ORAL 200MG Yes No 003 VIDEX EC DIDANOSINE CAPSULE, DELAYED REL PELLETS;ORAL 250MG Yes No 004 VIDEX EC DIDANOSINE CAPSULE, DELAYED REL PELLETS;ORAL 400MG Yes Yes
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date N021183-001 VIDEX EC DIDANOSINE 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 N021183-002 VIDEX EC DIDANOSINE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 N021183-003 VIDEX EC DIDANOSINE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 N021183-004 VIDEX EC DIDANOSINE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31
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UTC 2022-10 N021183-001 VIDEX EC 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021183-002 VIDEX EC 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021183-003 VIDEX EC 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021183-004 VIDEX EC 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021183-001 VIDEX EC 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021183-002 VIDEX EC 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021183-003 VIDEX EC 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021183-004 VIDEX EC 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021183-001 VIDEX EC 125MG CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021183-002 VIDEX EC 200MG CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021183-003 VIDEX EC 250MG CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021183-004 VIDEX EC 400MG CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021183-001 VIDEX EC 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021183-002 VIDEX EC 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021183-003 VIDEX EC 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021183-004 VIDEX EC 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, DELAYED REL PELLETS / ORAL RLD 2000-10-31 a50c72e98297…
Observed Orange Book normalized TE history# 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 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0087-6671 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current 0087-6671 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current 0087-6671 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current 0087-6672 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current 0087-6672 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current 0087-6672 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current 0087-6673 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current 0087-6673 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current 0087-6673 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current 0087-6674 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current 0087-6674 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current 0087-6674 VIDEX EC didanosine Bristol-Myers Squibb Company NDA Current