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Citi
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Cipla
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Cerilliant
UBS
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Federal Trade Commission

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050586

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NDA 050586 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 050586
Tradename:PRED-G
Applicant:Allergan
Ingredient:gentamicin sulfate; prednisolone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050586
Suppliers and Packaging for NDA: 050586
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRED-G gentamicin sulfate; prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 050586 NDA Allergan, Inc. 0023-0106 N 0023-0106-05
PRED-G gentamicin sulfate; prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 050586 NDA Allergan, Inc. 0023-0106 N 0023-0106-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrengthEQ 0.3% BASE;1%
Approval Date:Jun 10, 1988TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Harvard Business School
Merck
Boehringer Ingelheim
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US Army
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