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Serving leading biopharmaceutical companies globally:

Harvard Business School
Farmers Insurance
Express Scripts
Queensland Health

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050611

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NDA 050611 describes PCE, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the PCE profile page.

The generic ingredient in PCE is erythromycin. There are ninety-nine drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the erythromycin profile page.

Summary for 050611

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050611

Physiological EffectDecreased Sebaceous Gland Activity

Medical Subject Heading (MeSH) Categories for 050611

Suppliers and Packaging for NDA: 050611

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PCE erythromycin TABLET, COATED PARTICLES;ORAL 050611 NDA Arbor Pharmaceuticals, Inc. 24338-112 24338-112-60 100 TABLET in 1 BOTTLE (24338-112-60)
PCE erythromycin TABLET, COATED PARTICLES;ORAL 050611 NDA Arbor Pharmaceuticals, Inc. 24338-114 24338-114-13 100 TABLET in 1 BOTTLE (24338-114-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, COATED PARTICLES;ORALStrength333MG
Approval Date:Sep 9, 1986TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, COATED PARTICLES;ORALStrength500MG
Approval Date:Aug 22, 1990TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Fish and Richardson

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