FDA.reportPublic FDA data

Application 077167

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIDANOSINEDIDANOSINECAPSULE, DELAYED REL PELLETS;ORAL200MGNoNo
002DIDANOSINEDIDANOSINECAPSULE, DELAYED REL PELLETS;ORAL250MGNoNo
003DIDANOSINEDIDANOSINECAPSULE, DELAYED REL PELLETS;ORAL400MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077167-001DIDANOSINEDIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03
A077167-002DIDANOSINEDIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03
A077167-003DIDANOSINEDIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03

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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077167-002DIDANOSINE250MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077167-003DIDANOSINE400MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077167-001DIDANOSINE200MGCAPSULE, DELAYED REL PELLETS / ORAL2004-12-038072bd15b7f6…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0588DidanosineDidanosineTeva Pharmaceuticals USA,ANDACurrent
0555-0589DidanosineDidanosineTeva Pharmaceuticals USA,ANDACurrent
0555-0590DidanosineDidanosineTeva Pharmaceuticals USA,ANDACurrent
53808-0236DidanosineDidanosineState of Florida DOH Central PharmacyANDACurrent
53808-0353DidanosineDidanosineState of Florida DOH Central PharmacyANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9014ORIG2004-12-06