FDA.reportPublic FDA data

Application 078957

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STAVUDINESTAVUDINECAPSULE;ORAL15MGNoNo
002STAVUDINESTAVUDINECAPSULE;ORAL20MGNoNo
003STAVUDINESTAVUDINECAPSULE;ORAL30MGNoNo
004STAVUDINESTAVUDINECAPSULE;ORAL40MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078957-001STAVUDINESTAVUDINE15MGCAPSULE / ORAL2008-12-29
A078957-002STAVUDINESTAVUDINE20MGCAPSULE / ORAL2008-12-29
A078957-003STAVUDINESTAVUDINE30MGCAPSULE / ORAL2008-12-29
A078957-004STAVUDINESTAVUDINE40MGCAPSULE / ORAL2008-12-29

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 5 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A078957-001STAVUDINE15MGCAPSULE / ORAL2008-12-29f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078957-002STAVUDINE20MGCAPSULE / ORAL2008-12-29f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078957-003STAVUDINE30MGCAPSULE / ORAL2008-12-29f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078957-004STAVUDINE40MGCAPSULE / ORAL2008-12-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078957-001STAVUDINE15MGCAPSULE / ORAL2008-12-29e64feba35796…
2022-09-29 23:25 UTC2022-09A078957-002STAVUDINE20MGCAPSULE / ORAL2008-12-29e64feba35796…
2022-09-29 23:25 UTC2022-09A078957-003STAVUDINE30MGCAPSULE / ORAL2008-12-29e64feba35796…
2022-09-29 23:25 UTC2022-09A078957-004STAVUDINE40MGCAPSULE / ORAL2008-12-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078957-001STAVUDINE15MGCAPSULE / ORAL2008-12-29cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078957-002STAVUDINE20MGCAPSULE / ORAL2008-12-29cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078957-003STAVUDINE30MGCAPSULE / ORAL2008-12-29cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078957-004STAVUDINE40MGCAPSULE / ORAL2008-12-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078957-001STAVUDINE15MGCAPSULE / ORAL2008-12-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078957-002STAVUDINE20MGCAPSULE / ORAL2008-12-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078957-003STAVUDINE30MGCAPSULE / ORAL2008-12-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078957-004STAVUDINE40MGCAPSULE / ORAL2008-12-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A078957-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078957-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078957-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078957-004AB174a2ff9319b5…
2019-09-15 20:21 UTC2019-09A078957-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078957-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078957-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078957-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078957-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078957-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078957-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078957-004AB1ea99ee380514…

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-515StavudineStavudineCamber Pharmaceuticals, Inc.ANDACurrent
31722-516StavudineStavudineCamber Pharmaceuticals, Inc.ANDACurrent
31722-517StavudineStavudineCamber Pharmaceuticals, Inc.ANDACurrent
31722-518StavudineStavudineCamber Pharmaceuticals, Inc.ANDACurrent
53808-0595StavudineStavudineState of Florida DOH Central PharmacyANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9204ORIG2008-12-31
9203ORIG2008-03-04