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 4 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
2022-09-29 23:25 UTC	2022-09	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077167-001	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077167-002	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077167-003	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2004-12-03	`a50c72e98297…`

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