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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 090549


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NDA 090549 describes PENICILLIN V POTASSIUM, which is a drug marketed by Belcher Pharms, Chartwell Rx, Mylan, Purepac Pharm, Aurobindo Pharma, Hikma Pharms, Ivax Sub Teva Pharms, and Sandoz, and is included in thirteen NDAs. It is available from seventeen 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-two drug master file entries for this compound. Nineteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 090549
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 Hikma Pharmaceuticals USA Inc. 0143-9836 0143-9836-01 100 TABLET, FILM COATED in 1 BOTTLE (0143-9836-01)
PENICILLIN V POTASSIUM penicillin v potassium TABLET;ORAL 090549 ANDA Hikma Pharmaceuticals USA Inc. 0143-9836 0143-9836-10 1000 TABLET, FILM COATED in 1 BOTTLE (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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