FDA.reportPublic FDA data

REMEDYREPACK, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30058417683005841768REMEDYREPACK, INC.1N2026-01-01625 Kolter Drive Suite 4 Indiana PA US 15701

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3440111734285909K250401AION TempShield™FLL2025-03-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FLL12025-03-14

NDC#

Terazosin

REMEDYREPACK INC.

Terazosin Hydrochloride

Duloxetine

REMEDYREPACK INC.

DULOXETINE HYDROCHLORIDE

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