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Last Updated: September 27, 2020

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Details for New Drug Application (NDA): 065220

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NDA 065220 describes NEOMYCIN SULFATE, which is a drug marketed by Bristol Myers Squibb, Lannett, Lannett Co Inc, Lilly, Nostrum Labs Inc, Roxane, Sandoz, Teva, Xgen Pharms, Bausch And Lomb, Pharmafair, Alcon Pharms Ltd, Fougera, and Pharmaderm, and is included in twenty NDAs. It is available from four suppliers. Additional details are available on the NEOMYCIN SULFATE profile page.

The generic ingredient in NEOMYCIN SULFATE is neomycin sulfate; triamcinolone acetonide. There are nineteen drug master file entries for this compound. Additional details are available on the neomycin sulfate; triamcinolone acetonide profile page.
Summary for 065220
Applicant:Xgen Pharms
Ingredient:neomycin sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 065220
Medical Subject Heading (MeSH) Categories for 065220
Suppliers and Packaging for NDA: 065220
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOMYCIN SULFATE neomycin sulfate TABLET;ORAL 065220 ANDA X-GEN Pharmaceuticals, Inc. 39822-0310 39822-0310-5 100 BLISTER PACK in 1 BOX, UNIT-DOSE (39822-0310-5) > 1 TABLET in 1 BLISTER PACK (39822-0310-7)
NEOMYCIN SULFATE neomycin sulfate TABLET;ORAL 065220 ANDA Hi-Tech Pharmacal Co. Inc. 50383-565 50383-565-10 100 TABLET in 1 BOTTLE, PLASTIC (50383-565-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 28, 2006TE:AARLD:No

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