BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Cantor Fitzgerald
Boehringer Ingelheim

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065435

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NDA 065435 describes PENICILLIN V POTASSIUM, which is a drug marketed by Am Antibiotics, Dava Pharms Inc, Mylan, Purepac Pharm, Aurobindo Pharma, Hikma Pharms, Ivax Sub Teva Pharms, and Sandoz, and is included in thirteen NDAs. It is available from twenty-six suppliers. Additional details are available on the PENICILLIN V POTASSIUM profile page.

The generic ingredient in PENICILLIN V POTASSIUM is penicillin v potassium. There are eighty-seven drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the penicillin v potassium profile page.

Summary for 065435

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065435


Suppliers and Packaging for NDA: 065435

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENICILLIN V POTASSIUM penicillin v potassium TABLET;ORAL 065435 ANDA Blenheim Pharmacal, Inc. 10544-075 10544-075-30 30 TABLET, FILM COATED in 1 BOTTLE (10544-075-30)
PENICILLIN V POTASSIUM penicillin v potassium TABLET;ORAL 065435 ANDA NorthStar Rx LLC 16714-234 16714-234-01 100 TABLET, FILM COATED in 1 BOTTLE (16714-234-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Apr 29, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Apr 29, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
Boehringer Ingelheim

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