SAJAZIR (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only

NDC 70709-013-01

SAJAZIRTM

Icatibant Injection

30 mg/3 mL (10 mg/mL)

Single-dose Prefilled Syringe

One 3 mL Prefilled Syringe

FOR SUBCUTANEOUS USE ONLY

Manufactured by:

Cipla Ltd., India

At M/s. Gland Pharma Limited, India

Manufactured for:

Manufactured for: Cycle Pharmaceuticals Ltd,

Cambridge, CB3 0FA, UK

30 of 3
(click image for full-size original)

Rx Only

NDC 70709-013-03

SAJAZIRTM

Icatibant Injection

30 mg/3 mL (10 mg/mL)

Single-dose Prefilled Syringe

One 3 mL Prefilled Syringe

Manufactured by: Cipla Ltd., India

At M/s. Gland Pharma Limited, India

Manufactured for:

Cycle Pharmaceuticals Ltd,

Cambridge, CB3 0FA, UK

30 mg per 30 mL
(click image for full-size original)

Rx Only

NDC 70709-013-01

SAJAZIRTM

Icatibant Injection

30 mg/3 mL (10 mg/mL)

Single-dose Prefilled Syringe

One 3 mL Prefilled Syringe

FOR SUBCUTANEOUS USE ONLY

Manufactured by:

Cipla Ltd., India

At M/s. Gland Pharma Limited, India

Manufactured for:

Manufactured for: Cycle Pharmaceuticals Ltd,

Cambridge, CB3 0FA, UK

30mg per 3 lm 1s
(click image for full-size original)

Rx Only

NDC 70709-013-03

SAJAZIRTM

Icatibant Injection

30 mg/3 mL (10 mg/mL)

Single-dose Prefilled Syringe

One 3 mL Prefilled Syringe

Manufactured by: Cipla Ltd., India

At M/s. Gland Pharma Limited, India

Manufactured for:

Cycle Pharmaceuticals Ltd,

Cambridge, CB3 0FA, UK

30mg per 3 mL 3s pack carton
(click image for full-size original)

Rx Only

NDC 70709-013-03

Single-dose, Single-use,

Prefilled syringe

SAJAZIRTM

Icatibant Injection

30 mg/3 mL (10 mg/mL)

FOR SUBCUTANEOUS USE ONLY

Carton contains:

One 3 mL Prefilled Syringe and one 25 G hypodermic needle.

Full prescribing information with patient injection instructions.

The syringe is closed with a protective cap.

30mg per 3 mL 3s pack inner carton
(click image for full-size original)
SAJAZIR icatibant injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70709-013
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ICATIBANT ACETATE (ICATIBANT) ICATIBANT 30 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID 3.96 mg in 3 mL
SODIUM CHLORIDE 22.35 mg in 3 mL
SODIUM HYDROXIDE 1.92 mg in 3 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70709-013-03 3 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS
1 3 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (70709-013-03)
2 NDC:70709-013-01 1 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS
2 3 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (70709-013-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212446 06/03/2021
Labeler — Cycle Pharmaceuticals Ltd-Uk (218215530)
Registrant — Cipla USA Inc. (078719707)
Establishment
Name Address ID/FEI Operations
Gland Pharma Limited,Hyderabad, Telangana 918601238 ANALYSIS (70709-013), LABEL (70709-013), MANUFACTURE (70709-013), PACK (70709-013), STERILIZE (70709-013)

Revised: 06/2021 Cycle Pharmaceuticals Ltd-Uk

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