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e.g. K171392  ·  Dexlansoprazole EIR  ·  ANDA 214432

64,754 Records tracked
8,580 Pending / open
2020–2026 Years covered
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64,754 records
Year
Type
Subject
Outcome
2024
483
Form 483 — TMRW Biorepository LLC (Orlando, FL)
Inspection report · CDRH
Released
2024
EIR
EIR — CBR Systems Inc., Tuscon AZ (Jan 2024)
Establishment Inspection Report · CDRH
Released
2024-4468 08/2024 · 81 days
Requested by THE NEW YORK TIMES
Hello, I am a reporter with the New York Times seeking the following document related to CBR Systems Inc. in Tuscon, AZ (FEI: 3003374183): Establishment Inspection Report #1227528 dated 01/17/2024. Thank you.
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2024
NDA
NDA — 018680 — Paragard T 380A, CooperSurgical
New Drug Application · CDER
Released
2025
ANDA
ANDA Approval Package — Generic Drug Application
CDER · Filed 2025-03-14
Pending
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