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Generated: December 18, 2017

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Details for New Drug Application (NDA): 050612

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NDA 050612 describes PRED-G, which is a drug marketed by Allergan and is included in two NDAs. It is available from one supplier. Additional details are available on the PRED-G profile page.

The generic ingredient in PRED-G is gentamicin sulfate; prednisolone acetate. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gentamicin sulfate; prednisolone acetate profile page.

Summary for 050612

Formulation / Manufacturing:see details

Pharmacology for NDA: 050612

Suppliers and Packaging for NDA: 050612

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRED-G gentamicin sulfate; prednisolone acetate OINTMENT;OPHTHALMIC 050612 NDA Allergan, Inc. 0023-0066 0023-0066-04 1 TUBE in 1 CARTON (0023-0066-04) > 3.5 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrengthEQ 0.3% BASE;0.6%
Approval Date:Dec 1, 1989TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Chinese Patent Office
US Army

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