Home Applications 079069 Application 079069
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 STAVUDINE STAVUDINE CAPSULE;ORAL 15MG No No 002 STAVUDINE STAVUDINE CAPSULE;ORAL 20MG No No 003 STAVUDINE STAVUDINE CAPSULE;ORAL 30MG No No 004 STAVUDINE STAVUDINE CAPSULE;ORAL 40MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079069-001 STAVUDINE STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 A079069-002 STAVUDINE STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 A079069-003 STAVUDINE STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 A079069-004 STAVUDINE STAVUDINE 40MG CAPSULE / ORAL 2008-12-29
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A079069-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A079069-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A079069-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A079069-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079069-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 e64feba35796…2022-09-29 23:25 UTC 2022-09 A079069-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 e64feba35796…2022-09-29 23:25 UTC 2022-09 A079069-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 e64feba35796…2022-09-29 23:25 UTC 2022-09 A079069-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079069-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079069-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079069-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079069-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A079069-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A079069-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A079069-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A079069-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 53808-0594 Stavudine Stavudine State of Florida DOH Central Pharmacy ANDA Current 53808-0852 Stavudine stavudine State of Florida DOH Central Pharmacy ANDA Current