Home Applications 022011 Application 022011
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TYZEKA TELBIVUDINE TABLET;ORAL 600MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022011-001 TYZEKA TELBIVUDINE 600MG TABLET / ORAL RLD 2006-10-25
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 · 43 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 2022-09-29 23:25 UTC 2022-09 N022011-001 TYZEKA 600MG TABLET / ORAL RLD 2006-10-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022011-001 TYZEKA 600MG TABLET / ORAL RLD 2006-10-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022011-001 TYZEKA 600MG TABLET / ORAL RLD 2006-10-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 76 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022011-001 7589079 2023-09-11 U-999 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022011-001 7858594 2023-09-11 U-999 Drug substance, Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022011-001 7589079 2023-09-11 U-999 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022011-001 7858594 2023-09-11 U-999 Drug substance, Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022011-001 7589079 2023-09-11 U-999 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022011-001 7858594 2023-09-11 U-999 Drug substance, Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022011-001 6395716 2019-08-10 U-782 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022011-001 6444652 2019-08-10 U-782 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022011-001 6566344 2019-08-10 U-782 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022011-001 7795238 2019-08-10 U-999 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022011-001 6569837 2020-10-25 U-999 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022011-001 6569837 2020-10-25 U-782 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022011-001 7589079 2023-09-11 U-999 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022011-001 7858594 2023-09-11 U-999 Drug substance, Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022011-001 7589079 2023-09-11 U-999 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022011-001 7858594 2023-09-11 U-999 Drug substance, Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022011-001 7589079 2023-09-11 U-999 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022011-001 7858594 2023-09-11 U-999 Drug substance, Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022011-001 7589079 2023-09-11 U-999 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022011-001 7858594 2023-09-11 U-999 Drug substance, Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022011-001 7589079 2023-09-11 U-999 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022011-001 7858594 2023-09-11 U-999 Drug substance, Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022011-001 6569837 2020-10-25 U-999 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022011-001 6569837 2020-10-25 U-782 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022011-001 7589079 2023-09-11 U-999 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022011-001 7858594 2023-09-11 U-999 Drug substance, Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022011-001 6569837 2020-10-25 U-999 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022011-001 6569837 2020-10-25 U-782 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022011-001 7589079 2023-09-11 U-999 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022011-001 7858594 2023-09-11 U-999 Drug substance, Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022011-001 6395716 2019-08-10 U-782 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022011-001 6444652 2019-08-10 U-782 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022011-001 6566344 2019-08-10 U-782 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022011-001 7795238 2019-08-10 U-999 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022011-001 6569837 2020-10-25 U-999 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022011-001 6569837 2020-10-25 U-782 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022011-001 7589079 2023-09-11 U-999 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022011-001 7858594 2023-09-11 U-999 Drug substance, Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022011-001 6395716 2019-08-10 U-782 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022011-001 6444652 2019-08-10 U-782 b00525d2431f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.