PRED PHOS-GATI-BROM- prednisolone phosphate - gatifloxacin - bromfenac solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM), GATIFLOXACIN (UNII: L4618BD7KJ) (GATIFLOXACIN ANHYDROUS - UNII:81485Y3A9A), BROMFENAC (UNII: 864P0921DW) (BROMFENAC - UNII:864P0921DW)

Available from:

Imprimis NJOF, LLC

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

PRED PHOS-GATI-BROM- PREDNISOLONE PHOSPHATE - GATIFLOXACIN - BROMFENAC
SOLUTION/ 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)
PRED PHOS-GATI-BROM
prednisolone phosphate - gatifloxacin - bromfenac solution/ drops
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:7138 4-550
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PREDNISO LO NE SO DIUM PHO SPHATE (UNII: IV0 21NXA9 J) (PREDNISOLONE -
UNII:9 PHQ9 Y1OLM)
PREDNISOLONE 21-
PHOSPHATE
10 mg
in 1 mL
GATIFLO XACIN (UNII: L46 18 BD7KJ) (GATIFLOXACIN ANHYDROUS -
UNII:8 148 5Y3A9 A)
GATIFLOXACIN
5 mg in 1 mL
BRO MFENAC (UNII: 8 6 4P0 9 21DW) (BROMFENAC - UNII:8 6 4P0 9 21DW)
BROMFENAC
0 .75 mg
in 1 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:7138 4-550 -
0 3
3.5 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n
Pro duc t
0 7/0 2/20 18
2
NDC:7138 4-550 -
0 7
7 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n
Pro duc t
0 7/0 2/20 18
Imprimis NJOF, LLC
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 7/0 2/20 18
LABELER -
Imprimis NJOF, LLC (080431967)
Revised: 6/2018