PRED-GATI- prednisolone acetate-gatifloxacin suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GATIFLOXACIN (UNII: L4618BD7KJ) (GATIFLOXACIN ANHYDROUS - UNII:81485Y3A9A), PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

Available from:

Imprimis NJOF, LLC

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

PRED-GATI- PREDNISOLONE ACETATE-GATIFLOXACIN SUSPENSION/ DROPS
IMPRIMIS NJOF, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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STORE AT 20° TO 25° C (68° TO 77° F)
PACKAGE LABEL
PRED-GATI
prednisolone acetate-gatifloxacin suspension/ drops
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:7138 4-50 2
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
GATIFLO XACIN (UNII: L46 18 BD7KJ) (GATIFLOXACIN ANHYDROUS -
UNII:8 148 5Y3A9 A)
GATIFLOXACIN
5 mg in 1 mL
PREDNISO LO NE ACETATE (UNII: 8 B28 0 7733D) (PREDNISOLONE -
UNII:9 PHQ9 Y1OLM)
PREDNISOLONE
ACETATE
10 mg
in 1 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:7138 4-50 2-
0 3
20 in 1 BOX
0 1/0 5/20 18
1
3.5 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n
Imprimis NJOF, LLC
1
Pro duc t
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
0 1/0 5/20 18
LABELER -
Imprimis NJOF, LLC (080431967)
Revised: 1/2018