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	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N021183-001	VIDEX EC	DIDANOSINE	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2000-10-31
N021183-002	VIDEX EC	DIDANOSINE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2000-10-31
N021183-003	VIDEX EC	DIDANOSINE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2000-10-31
N021183-004	VIDEX EC	DIDANOSINE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2000-10-31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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021183-001	VIDEX EC	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2000-10-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021183-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021183-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021183-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021183-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021183-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021183-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021183-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021183-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021183-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021183-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021183-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021183-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021183-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021183-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021183-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021183-004	AB	1	`ea99ee380514…`

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56915	SUPPL	2018-12-21
56770	SUPPL	2018-12-18
56769	SUPPL	2018-12-18
52103	SUPPL	2018-01-30
52079	SUPPL	2018-01-25
14603	SUPPL	2011-11-22
4594	SUPPL	2011-11-22
4593	SUPPL	2011-05-12
44103	ORIG	2010-08-09
4592	SUPPL	2010-02-01
14602	SUPPL	2010-01-29
14601	SUPPL	2009-06-22
27019	SUPPL	2009-06-16
36312	SUPPL	2008-10-03
4591	SUPPL	2008-10-02
21496	SUPPL	2007-07-09
4590	SUPPL	2006-12-28
14600	SUPPL	2006-12-04
27018	SUPPL	2006-09-18
36311	SUPPL	2006-08-21
42008	SUPPL	2005-04-08
4584	ORIG	2004-06-30
21495	ORIG	2004-03-11
36310	SUPPL	2004-01-22
4589	SUPPL	2004-01-22
27017	SUPPL	2003-03-10
14599	SUPPL	2003-03-07
36309	SUPPL	2002-09-26
27016	SUPPL	2002-09-26
14598	SUPPL	2002-09-26
4588	SUPPL	2002-09-26
14597	SUPPL	2002-08-05
4587	SUPPL	2002-08-05
36308	SUPPL	2002-04-01
27015	SUPPL	2002-04-01
4586	SUPPL	2002-01-29
4585	SUPPL	2002-01-28
36307	ORIG	2000-10-31
53231	SUPPL	1900-01-01
53230	SUPPL	1900-01-01