FDA.reportPublic FDA data

Application 077672

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

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

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
A077672-001STAVUDINESTAVUDINE30MGCAPSULE / ORAL2008-12-29
A077672-002STAVUDINESTAVUDINE40MGCAPSULE / ORAL2008-12-29
A077672-003STAVUDINESTAVUDINE15MGCAPSULE / ORAL2008-12-29
A077672-004STAVUDINESTAVUDINE20MGCAPSULE / 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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A077672-001STAVUDINE30MGCAPSULE / ORALAB2008-12-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077672-002STAVUDINE40MGCAPSULE / ORALAB2008-12-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077672-003STAVUDINE15MGCAPSULE / ORALAB2008-12-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077672-004STAVUDINE20MGCAPSULE / ORALAB2008-12-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077672-001STAVUDINE30MGCAPSULE / ORAL2008-12-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077672-002STAVUDINE40MGCAPSULE / ORAL2008-12-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077672-003STAVUDINE15MGCAPSULE / ORAL2008-12-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077672-004STAVUDINE20MGCAPSULE / ORAL2008-12-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077672-001STAVUDINE30MGCAPSULE / ORAL2008-12-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A077672-002STAVUDINE40MGCAPSULE / ORAL2008-12-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A077672-003STAVUDINE15MGCAPSULE / ORAL2008-12-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A077672-004STAVUDINE20MGCAPSULE / ORAL2008-12-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077672-001STAVUDINE30MGCAPSULE / ORAL2008-12-2987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077672-002STAVUDINE40MGCAPSULE / ORAL2008-12-2987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077672-003STAVUDINE15MGCAPSULE / ORAL2008-12-2987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077672-004STAVUDINE20MGCAPSULE / ORAL2008-12-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A077672-001STAVUDINE30MGCAPSULE / ORAL2008-12-295aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077672-002STAVUDINE40MGCAPSULE / ORAL2008-12-295aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077672-003STAVUDINE15MGCAPSULE / ORAL2008-12-295aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077672-004STAVUDINE20MGCAPSULE / ORAL2008-12-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077672-001STAVUDINE30MGCAPSULE / ORAL2008-12-298869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077672-002STAVUDINE40MGCAPSULE / ORAL2008-12-298869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077672-003STAVUDINE15MGCAPSULE / ORAL2008-12-298869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077672-004STAVUDINE20MGCAPSULE / ORAL2008-12-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077672-001STAVUDINE30MGCAPSULE / ORAL2008-12-29c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077672-002STAVUDINE40MGCAPSULE / ORALRS2008-12-29c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077672-003STAVUDINE15MGCAPSULE / ORAL2008-12-29c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077672-004STAVUDINE20MGCAPSULE / ORAL2008-12-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077672-001STAVUDINE30MGCAPSULE / ORALAB2008-12-293f01610625f2…
2019-12-14 00:12 UTC2019-12A077672-002STAVUDINE40MGCAPSULE / ORALAB2008-12-293f01610625f2…
2019-12-14 00:12 UTC2019-12A077672-003STAVUDINE15MGCAPSULE / ORALAB2008-12-293f01610625f2…
2019-12-14 00:12 UTC2019-12A077672-004STAVUDINE20MGCAPSULE / ORALAB2008-12-293f01610625f2…
2019-09-15 20:21 UTC2019-09A077672-001STAVUDINE30MGCAPSULE / ORALAB2008-12-29b00525d2431f…
2019-09-15 20:21 UTC2019-09A077672-002STAVUDINE40MGCAPSULE / ORALAB2008-12-29b00525d2431f…
2019-09-15 20:21 UTC2019-09A077672-003STAVUDINE15MGCAPSULE / ORALAB2008-12-29b00525d2431f…
2019-09-15 20:21 UTC2019-09A077672-004STAVUDINE20MGCAPSULE / ORALAB2008-12-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A077672-001STAVUDINE30MGCAPSULE / ORALAB2008-12-29ea99ee380514…
2019-07-19 19:46 UTC2019-07A077672-002STAVUDINE40MGCAPSULE / ORALAB2008-12-29ea99ee380514…
2019-07-19 19:46 UTC2019-07A077672-003STAVUDINE15MGCAPSULE / ORALAB2008-12-29ea99ee380514…
2019-07-19 19:46 UTC2019-07A077672-004STAVUDINE20MGCAPSULE / ORALAB2008-12-29ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077672-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077672-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077672-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077672-004AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077672-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077672-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077672-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077672-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077672-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077672-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077672-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077672-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077672-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077672-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077672-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077672-004AB1ea99ee380514…

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57237-234StavudineStavudineCitron Pharma LLCANDACurrent
57237-235StavudineStavudineCitron Pharma LLCANDACurrent
57237-236StavudineStavudineCitron Pharma LLCANDACurrent
57237-237StavudineStavudineCitron Pharma LLCANDACurrent
64980-354StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-354StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-355StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-355StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-356StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-356StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-357StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-357StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
65862-046StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-046StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-047StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-047StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-111StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-111StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-112StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-112StavudineStavudineAurobindo Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18468ORIG2009-02-04
31275ORIG2008-12-30
31274ORIG2006-07-03
31273ORIG2005-07-08