Home Applications 065454 Application 065454
Type ANDA
Sponsor CHARTWELL LIFE SCI Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOXYCYCLINE DOXYCYCLINE FOR SUSPENSION;ORAL EQ 25MG BASE/5ML 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 A065454-001 DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065454-001 AB
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 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 62135-417 Doxycycline Doxycycline Chartwell RX LLC ANDA Current 62135-417 Doxycycline Doxycycline Chartwell RX LLC ANDA Current 62135-417 doxycycline doxycycline Chartwell RX LLC ANDA Current 62135-417 doxycycline doxycycline Chartwell RX LLC ANDA Current 62135-417 doxycycline doxycycline Chartwell RX LLC ANDA Current 62135-417 doxycycline doxycycline Chartwell RX LLC ANDA Current 67405-475 Doxycycline DOXYCYCLINE Harris Pharmaceutical, Inc ANDA Current 68999-417 doxycycline doxycycline Chartwell Governmental & Specialty RX, LLC ANDA Current 68999-417 doxycycline doxycycline Chartwell Governmental & Specialty RX, LLC ANDA Current 68999-417 doxycycline doxycycline Chartwell Governmental & Specialty RX, LLC ANDA Current 69097-228 Doxycycline DOXYCYCLINE CIPLA USA, Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 39426 ORIG 2008-07-22 30663 ORIG 2008-07-17