MedPath
FDA Approval

Flector

July 17, 2012

HUMAN PRESCRIPTION DRUG LABEL

Diclofenac(180 mg in 1 1)

Registrants (1)

PSS World Medical, Inc.

101822862

Manufacturing Establishments (6)

SCRIPT PAK

Rebel Distributors Corp

PSS World Medical, Inc.

964420108

PSS World Medical, Inc.

Rebel Distributors Corp

PSS World Medical, Inc.

791528623

Dispensing Solutions, Inc.

Rebel Distributors Corp

PSS World Medical, Inc.

066070785

Keltman Pharmaceuticals, Inc.

Rebel Distributors Corp

PSS World Medical, Inc.

362861077

Rebel Distirbutors Corp.

Rebel Distributors Corp

PSS World Medical, Inc.

118802834

STAT RX USA LLC

Rebel Distributors Corp

PSS World Medical, Inc.

786036330

Products (1)

Flector

42254-248

NDA021234

NDA (C73594)

TOPICAL

July 26, 2011

Code: X5F8EKL9ZGClass: ACTIBQuantity: 180 mg in 1 1
SorbitolInactive
Code: 506T60A25RClass: IACT
Dihydroxyaluminum AminoacetateInactive
Code: DO250MG0W6Class: IACT
Edetate DisodiumInactive
Code: 7FLD91C86KClass: IACT
Tartaric AcidInactive
Code: W4888I119HClass: IACT
GelatinInactive
Code: 2G86QN327LClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
KaolinInactive
Code: 24H4NWX5COClass: IACT
MethylparabenInactive
Code: A2I8C7HI9TClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
PropylparabenInactive
Code: Z8IX2SC1OHClass: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3Class: IACT
Carboxymethylcellulose SodiumInactive
Code: K679OBS311Class: IACT
Butylene GlycolInactive
Code: 3XUS85K0RAClass: IACT
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