Home Applications 020869 Application 020869
Type NDA
Sponsor OAK PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COSOPT DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Yes Yes
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 N020869-001 COSOPT DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 1998-04-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020869-001 AT1
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 N020869-001 COSOPT EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1998-04-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020869-001 COSOPT EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1998-04-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020869-001 COSOPT EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1998-04-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020869-001 COSOPT EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 1998-04-07 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COSOPT DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE Thea Pharma Inc. 23bdf1c1-3134-4ad1-8e7c-bc655156bdc6 2024-04-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 020869 application number: NDA020869 ndc (product): 82584-605
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-605 COSOPT Dorzolamide Hydrochloride and Timolol Maleate Akorn NDA Current 17478-605 COSOPT Dorzolamide Hydrochloride and Timolol Maleate Akorn NDA Current 17478-605 COSOPT Dorzolamide Hydrochloride and Timolol Maleate Akorn NDA Current 17478-605 COSOPT Dorzolamide Hydrochloride and Timolol Maleate Akorn NDA Current 17478-605 COSOPT Dorzolamide Hydrochloride and Timolol Maleate Akorn NDA Current 17478-605 COSOPT Dorzolamide Hydrochloride and Timolol Maleate Akorn NDA Current 82584-605 COSOPT dorzolamide hydrochloride and timolol maleate Thea Pharma Inc. NDA Current