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 43 .
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 2 of 4 · 129 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 2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 3f01610625f2…
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