Home Applications 050475 Application 050475
Type NDA
Sponsor VALEANT PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GRIS-PEG GRISEOFULVIN, ULTRAMICROSIZE TABLET;ORAL 125MG Yes No 002 GRIS-PEG GRISEOFULVIN, ULTRAMICROSIZE TABLET;ORAL 250MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050475-001 GRIS-PEG GRISEOFULVIN, ULTRAMICROSIZE 125MG TABLET / ORAL AB RLD, Approved before 1982 N050475-002 GRIS-PEG GRISEOFULVIN, ULTRAMICROSIZE 250MG TABLET / ORAL AB RLD, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 88 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 N050475-001 GRIS-PEG 125MG TABLET / ORAL AB RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050475-002 GRIS-PEG 250MG TABLET / ORAL AB RLD, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050475-001 GRIS-PEG 125MG TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050475-002 GRIS-PEG 250MG TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050475-001 GRIS-PEG 125MG TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050475-002 GRIS-PEG 250MG TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050475-001 GRIS-PEG 125MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050475-002 GRIS-PEG 250MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0884-0763 Gris-PEG griseofulvin Pedinol Pharmacal, Inc. NDA Current 0884-0773 Gris-PEG griseofulvin Pedinol Pharmacal, Inc. NDA Current 53808-0261 Gris-PEG GRISEOFULVIN State of Florida DOH Central Pharmacy NDA Current 68682-519 Griseofulvin Griseofulvin Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-520 Griseofulvin Griseofulvin Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 83957 SUPPL 2025-10-28 83956 SUPPL 2025-10-28 7764 SUPPL 2016-04-22 17843 SUPPL 2016-04-20 30043 SUPPL 2010-10-25 17842 SUPPL 2010-10-19 38949 SUPPL 2007-02-02 7763 SUPPL 2007-02-02 30042 SUPPL 2003-04-14 17841 SUPPL 2003-03-28