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Generated: April 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090549

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NDA 090549 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 ninety 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 090549
Tradename:PENICILLIN V POTASSIUM
Applicant:Hikma Pharms
Ingredient:penicillin v potassium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 090549
Ingredient-typePenicillins
Suppliers and Packaging for NDA: 090549
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENICILLIN V POTASSIUM penicillin v potassium TABLET;ORAL 090549 ANDA West-Ward Pharmaceuticals Corp 0143-9836 N 0143-9836-01
PENICILLIN V POTASSIUM penicillin v potassium TABLET;ORAL 090549 ANDA West-Ward Pharmaceuticals Corp 0143-9836 N 0143-9836-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Oct 11, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Oct 11, 2013TE:ABRLD:No

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