Home Applications 086195 Application 086195
Type ANDA
Sponsor MYLAN SPECIALITY LP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROCTOFOAM HC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE AEROSOL, METERED;TOPICAL 1%;1% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A086195-001 PROCTOFOAM HC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 1%;1% AEROSOL, METERED / TOPICAL BX RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A086195-001 BX
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 2 · 44 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 A086195-001 PROCTOFOAM HC 1%;1% AEROSOL, METERED / TOPICAL BX RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A086195-001 PROCTOFOAM HC 1%;1% AEROSOL, METERED / TOPICAL BX RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A086195-001 PROCTOFOAM HC 1%;1% AEROSOL, METERED / TOPICAL BX RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A086195-001 PROCTOFOAM HC 1%;1% AEROSOL, METERED / TOPICAL BX RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0037-6822 PROCTOFOAM pramoxine hydrochloride hydrocortisone acetate Meda Pharmaceuticals ANDA Current 0037-6822 PROCTOFOAM pramoxine hydrochloride hydrocortisone acetate Meda Pharmaceuticals ANDA Current 0037-6822 PROCTOFOAM pramoxine hydrochloride hydrocortisone acetate Meda Pharmaceuticals Inc. ANDA Current 21695-982 Proctofoam hydrocortisone acetate and pramoxine hydrochloride Rebel Distributors Corp ANDA Current