Akovaz (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — NDC: 68001-330-59 — 1 mL Vial Label

S:\Departments\BPLabs\Quality  & Regulatory\Regulatory\ARTWORK FILES BLUEPOINT\Avadel\Ephedrine Sulfate (Akovaz)\Siegfried Site\Ephedrine Sulfate (Akovaz) Rev 10-17 Label Approved without Signature (Siegfried Site).JPG
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PRINCIPAL DISPLAY PANEL — NDC: 68001-330-60 — 25-count Carton Label

S:\Departments\BPLabs\Quality  & Regulatory\Regulatory\ARTWORK FILES BLUEPOINT\Avadel\Ephedrine Sulfate (Akovaz)\Siegfried Site\Ephedrine Sulfate (Akovaz) Rev 10-17 Carton Approved without Signature (Siegfried Site).JPG
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AKOVAZ
ephedrine sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-330
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPHEDRINE SULFATE (EPHEDRINE) EPHEDRINE SULFATE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ACETIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-330-60 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (68001-330-59)
1 NDC:68001-330-59 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (68001-330-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208289 06/30/2017
Labeler — BluePoint Laboratories (985523874)
Registrant — Flamel Ireland Limited (985592446)
Establishment
Name Address ID/FEI Operations
Patheon Italia S.p.A 338336589 MANUFACTURE (68001-330)
Establishment
Name Address ID/FEI Operations
Siegfried Hameln GmbH 315869123 MANUFACTURE (68001-330)

Revised: 08/2018 BluePoint Laboratories

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