Home Applications 050810 Application 050810
Type NDA
Sponsor OAK PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AZASITE AZITHROMYCIN SOLUTION/DROPS;OPHTHALMIC 1% 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 N050810-001 AZASITE AZITHROMYCIN 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27
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 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N050810-001 6239113 2019-03-31 U-709 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050810-001 6569443 2019-03-31 U-709 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050810-001 7056893 2019-03-31 U-709 Drug product 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N050810-001 6239113 2019-03-31 U-709 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050810-001 6569443 2019-03-31 U-709 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050810-001 7056893 2019-03-31 U-709 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050810-001 6239113 2019-03-31 U-709 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050810-001 6569443 2019-03-31 U-709 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050810-001 7056893 2019-03-31 U-709 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050810-001 6239113 2019-03-31 U-709 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050810-001 6569443 2019-03-31 U-709 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050810-001 7056893 2019-03-31 U-709 Drug product ea99ee380514…
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-307 AzaSITE Azithromycin Monohydrate Akorn NDA Current 17478-307 AzaSITE Azithromycin Monohydrate Akorn, Inc. NDA Current 17478-307 AzaSITE Azithromycin Monohydrate Akorn, Inc. NDA Current 17478-307 AzaSITE Azithromycin Monohydrate Akorn, Inc. NDA Current 82584-307 AZASITE azithromycin monohydrate Thea Pharma Inc. NDA Current 82584-307 AZASITE azithromycin monohydrate Thea Pharma Inc. NDA Current