Home Applications 075286 Application 075286
Type ANDA
Sponsor FOSUN PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PEMOLINE PEMOLINE TABLET;ORAL 18.75MG No No 002 PEMOLINE PEMOLINE TABLET;ORAL 37.5MG No No 003 PEMOLINE PEMOLINE TABLET;ORAL 75MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 TE codes RLD / RS Approval date A075286-001 PEMOLINE PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 A075286-002 PEMOLINE PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 A075286-003 PEMOLINE PEMOLINE 75MG TABLET / ORAL 1999-06-30
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 · 132 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 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 8599 ORIG 1999-06-30