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 Type | HUMAN PRESCRIPTION DRUG | Item Code (Source) | NDC: 71384-550 |
Route of Administration | OPHTHALMIC |
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Active Ingredient/Active Moiety |
Ingredient Name | Basis of Strength | Strength |
PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM) | PREDNISOLONE 21-PHOSPHATE | 10 mg in 1 mL |
GATIFLOXACIN (UNII: L4618BD7KJ) (GATIFLOXACIN ANHYDROUS - UNII:81485Y3A9A) | GATIFLOXACIN | 5 mg in 1 mL |
BROMFENAC (UNII: 864P0921DW) (BROMFENAC - UNII:864P0921DW) | BROMFENAC | 0.75 mg in 1 mL |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 71384-550-03 | 3.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product | 07/02/2018 | 07/01/2019 |
2 | NDC: 71384-550-07 | 7 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product | 07/02/2018 | 07/01/2019 |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
unapproved drug other | | 07/02/2018 | 07/01/2019 |
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Labeler - Imprimis NJOF, LLC
(080431967)
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Imprimis NJOF, LLC