Application 077167

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIDANOSINE	DIDANOSINE	CAPSULE, DELAYED REL PELLETS;ORAL	200MG	No	No
002	DIDANOSINE	DIDANOSINE	CAPSULE, DELAYED REL PELLETS;ORAL	250MG	No	No
003	DIDANOSINE	DIDANOSINE	CAPSULE, DELAYED REL PELLETS;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077167-001	DIDANOSINE	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03
A077167-002	DIDANOSINE	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03
A077167-003	DIDANOSINE	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`3f01610625f2…`

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0588	Didanosine	Didanosine	Teva Pharmaceuticals USA,	ANDA	Current
0555-0589	Didanosine	Didanosine	Teva Pharmaceuticals USA,	ANDA	Current
0555-0590	Didanosine	Didanosine	Teva Pharmaceuticals USA,	ANDA	Current
53808-0236	Didanosine	Didanosine	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0353	Didanosine	Didanosine	State of Florida DOH Central Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9014	ORIG	2004-12-06