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CEQUA- cyclosporine solution/ drops


  1. Patient Information
  2. Distributed By:
  3. Revised: 10/2019document Id:

Patient Information 

Handling the Vial

Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may

contaminate the solution. Advise patients also not to touch the vial tip to their eye to avoid the

potential for injury to the eye[see Warnings and Precautions (5.1)].

Use with Contact Lenses

CEQUA should not be administered while wearing contact lenses. Patients with decreased tear

production typically should not wear contact lenses. Advise patients that if contact lenses are

worn, they should be removed prior to the administration of the solution. Lenses may be

reinserted 15 minutes following administration of CEQUA ophthalmic solution[see Warnings

and Precautions (5.2)].

Administration

Advise patients that the solution from one individual single-use vial is to be used immediately

after opening for administration to one or both eyes, and the remaining contents should be

discarded immediately after administration.

Rx Only

Manufactured for: Sun Pharma Global FZE

By: Laboratoire Unither

ZI de la Gu rie

F-50211 Coutances Cedex

France

Product of France

Distributed By: 

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Copyright 2019, Sun Pharma Global FZE

All rights reserved

09/2019

uspi-CEQUA-sol-00002

PRINCIPAL DISPLAY PANEL

NDC 47355-506-96

For topical use in the eye
sterile, Preservative-Free

CequaTM
(cyclosporine ophthalmic solution) 0.09%

60 SINGLE-USE VIALS

6 pouches x 10 single-use vials (0.25 mL each)

Rx only

Keep out of reach of children.
Not child resistant.

SUN PHARMA

IMAGE_2

PRINCIPAL DISPLAY PANEL

NDC 47355-507-97

For topical use in the eye
sterile, Preservative-Free

CequaTM
(cyclosporine ophthalmic solution) 0.09%

10 SINGLE-USE SAMPLE VIALS

1 pouches x 10 single-use vials (0.25 mL each)

Rx only

Keep out of reach of children.
Not child resistant.

SUN PHARMA

IMAGE_3
CEQUA
cyclosporine solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:47335-506
Route of AdministrationOPHTHALMIC, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYCLOSPORINE(UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)CYCLOSPORINE0.0009 g in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)0.01 g in 1 mL
OCTOXYNOL-40(UNII: 9T1C662FKS)0.0005 g in 1 mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(UNII: 5QWK665956)0.0053 g in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)0.0047 g in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.0005 g in 1 mL
POVIDONE K90(UNII: RDH86HJV5Z)0.003 g in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47335-506-966 in 1 BOX08/15/2018
110 in 1 POUCH
10.25 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21091308/15/2018
CEQUA
cyclosporine solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:47335-507
Route of AdministrationOPHTHALMIC, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYCLOSPORINE(UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)CYCLOSPORINE0.0009 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)0.01 g in 1 mL
OCTOXYNOL-40(UNII: 9T1C662FKS)0.0005 g in 1 mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(UNII: 5QWK665956)0.0053 g in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)0.0047 g in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.0005 g in 1 mL
POVIDONE K90(UNII: RDH86HJV5Z)0.003 g in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47335-507-971 in 1 BOX08/15/2018
110 in 1 POUCH
10.25 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21091308/15/2018
Labeler -Sun Pharmaceutical Industries, Inc. (146974886)
Registrant -Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries, Inc.146974886MANUFACTURE(47335-506, 47335-507)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoire Unither574139809MANUFACTURE(47335-506, 47335-507)

Revised: 10/2019document Id: 

457c468a-66b8-4d52-805e-deccedd0711aSet id: 48c3d8a3-4289-4b52-9189-58b48596095cVersion: 4Effective Time: 20191014Sun Pharmaceutical Industries, Inc.



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