Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022186

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AK-FLUOR 10% (FLUORESCEIN SODIUM)
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: FLUORESCEIN SODIUM
Proprietary Name: AK-FLUOR 10%
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022186
Product Number: 001
Approval Date: Aug 8, 2008
Applicant Holder Full Name: LONG GROVE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

AK-FLUOR 25% (FLUORESCEIN SODIUM)
EQ 500MG BASE/2ML (EQ 250MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: FLUORESCEIN SODIUM
Proprietary Name: AK-FLUOR 25%
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 500MG BASE/2ML (EQ 250MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022186
Product Number: 002
Approval Date: Aug 8, 2008
Applicant Holder Full Name: LONG GROVE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information