Application 020156

Type
NDA
Sponsor
BRISTOL-MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIDEXDIDANOSINEFOR SOLUTION;ORAL10MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020156-001VIDEXDIDANOSINE10MG/MLFOR SOLUTION / ORALRLD1991-10-09

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD, RS1991-10-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD, RS1991-10-093f01610625f2…
2019-09-15 20:21 UTC2019-09N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD, RS1991-10-09b00525d2431f…
2019-07-19 19:46 UTC2019-07N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD, RS1991-10-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-093f0d92c62455…
2023-05-13 08:27 UTC2023-05N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09053a50430f4f…
2023-01-26 05:58 UTC2023-01N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020156-001VIDEX10MG/MLFOR SOLUTION / ORALRLD1991-10-09cb3db0bc1861…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0087-6632VIDEXdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6632VIDEXdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6632VIDEXdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6633VIDEXdidanosineBristol-Myers Squibb CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56916SUPPL2018-12-21
56775SUPPL2018-12-18
56774SUPPL2018-12-18
52105SUPPL2018-01-30
51922SUPPL2018-01-26
51921SUPPL2018-01-26
12282SUPPL2014-08-12
2109SUPPL2014-08-12
34325SUPPL2011-11-22
21233SUPPL2011-11-22
2108SUPPL2011-05-12
44048ORIG2010-08-09
2107SUPPL2010-02-01
12281SUPPL2010-01-29
12280SUPPL2009-06-22
2106SUPPL2009-06-17
41181SUPPL2007-11-19
20498SUPPL2007-08-06
20497SUPPL2007-08-06
2105SUPPL2006-12-28
12279SUPPL2006-12-04
21232SUPPL2006-09-18
12278SUPPL2006-08-21
41180SUPPL2005-04-27
20501SUPPL2005-04-27
41179SUPPL2005-04-19
20500SUPPL2005-04-19
41178SUPPL2005-01-06
20499SUPPL2004-08-09
12277SUPPL2004-01-22
2104SUPPL2004-01-22
34323SUPPL2003-04-21
12273SUPPL2003-04-21
2103SUPPL2003-03-10
34324SUPPL2003-03-07
21231SUPPL2002-09-25
12276SUPPL2002-09-25
12275SUPPL2002-09-25
2102SUPPL2002-09-25
21230SUPPL2002-04-01
12274SUPPL2002-04-01
2101SUPPL1999-10-29
34322SUPPL1999-10-21