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 3 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 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…2019-12-14 00:12 UTC 2019-12 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075286-001 PEMOLINE 18.75MG TABLET / ORAL 1999-12-27 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075286-002 PEMOLINE 37.5MG TABLET / ORAL 1999-06-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075286-003 PEMOLINE 75MG TABLET / ORAL 1999-06-30 3a93d1ddd44b…
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