Griseofulvin Oral Suspension

GRISEOFULVIN ORAL SUSPENSION- griseofulvin suspension
TriRx Huntsville Pharmaceutical Services LLC

Adverse ReactionsAdverse reactions 2Adverse ReactionsAdverse reactions 2

CMF-1
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CMF-2
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Clinical Pharmacology

Clinical Pharmacology-2Clinical Pharmacology-3Clinical PharmacologyClinical Pharmacology-2Clinical Pharmacology-3

Contraindications-1Contraindications-2Contraindications-3Contraindications-1Contraindications-2Contraindications-3

Description-2Description-1

Dosage and Administration-1

Dosage and Administration-2dosage and administration 3Dosage and Administration-4dosage and administration 4Dosage and Administration-1Dosage and Administration-2dosage and administration 3Dosage and Administration-4dosage and administration 4

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How Supplied

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microbiology

Overdosage

Pediatric Use
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Precautions

pregnancy

Warnings and Precautions

HepatotoxicityWarnings and PrecautionsHepatotoxicity

Nursing Mothers
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primary package label-bottle
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GRISEOFULVIN ORAL SUSPENSION
griseofulvin oral suspension suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80432-056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRISEOFULVIN (GRISEOFULVIN) GRISEOFULVIN 125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE
ORANGE
METHYLPARABEN
DOCUSATE SODIUM
MAGNESIUM ALUMINUM SILICATE
MENTHOL, (+)-
PROPYLPARABEN
PROPYLENE GLYCOL, (R)-
WATER
ALCOHOL
FD&C YELLOW NO. 6
SACCHARIN SODIUM
FD&C RED NO. 40
SUCROSE
SODIUM ALGINATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80432-056-11 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065438 08/09/2022
Labeler — TriRx Huntsville Pharmaceutical Services LLC (117090286)
Establishment
Name Address ID/FEI Operations
TriRx Huntsville Pharmaceutical Services 117090286 manufacture (80432-056)

Revised: 01/2023 TriRx Huntsville Pharmaceutical Services LLC

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