Details for New Drug Application (NDA): 022186
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The generic ingredient in AK-FLUOR 25% is fluorescein sodium. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluorescein sodium profile page.
Summary for 022186
Tradename: | AK-FLUOR 25% |
Applicant: | Long Grove Pharms |
Ingredient: | fluorescein sodium |
Patents: | 0 |
Pharmacology for NDA: 022186
Mechanism of Action | Dyes |
Medical Subject Heading (MeSH) Categories for 022186
Suppliers and Packaging for NDA: 022186
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AK-FLUOR 10% | fluorescein sodium | INJECTABLE;INTRAVENOUS | 022186 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1533 | 51662-1533-3 | 12 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSE |
AK-FLUOR 10% | fluorescein sodium | INJECTABLE;INTRAVENOUS | 022186 | NDA | Long Grove Pharmaceuticals, LLC | 81298-8660 | 81298-8660-3 | 12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | ||||
Approval Date: | Aug 8, 2008 | TE: | AP | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 500MG BASE/2ML (EQ 250MG BASE/ML) | ||||
Approval Date: | Aug 8, 2008 | TE: | AP | RLD: | Yes |
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