You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Details for New Drug Application (NDA): 065448


✉ Email this page to a colleague

« Back to Dashboard


NDA 065448 describes PENICILLIN G POTASSIUM, which is a drug marketed by Mylan, Purepac Pharm, Acs Dobfar Spa, Apothecon, Consolidated Pharm, Hq Speclt Pharma, Istituto Bio Ita Spa, Lilly, Parke Davis, Pfizer, Sandoz, Watson Labs Inc, Ivax Sub Teva Pharms, Teva, Wyeth Ayerst, and Baxter Hlthcare, and is included in twenty-one NDAs. It is available from five suppliers. Additional details are available on the PENICILLIN G POTASSIUM profile page.

The generic ingredient in PENICILLIN G POTASSIUM is penicillin g potassium. There are ninety-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the penicillin g potassium profile page.
Summary for 065448
Tradename:PENICILLIN G POTASSIUM
Applicant:Istituto Bio Ita Spa
Ingredient:penicillin g potassium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065448
Suppliers and Packaging for NDA: 065448
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENICILLIN G POTASSIUM penicillin g potassium INJECTABLE;INJECTION 065448 ANDA Athenex Pharmaceutical Division, LLC. 70860-126 70860-126-20 10 VIAL in 1 CARTON (70860-126-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70860-126-41)
PENICILLIN G POTASSIUM penicillin g potassium INJECTABLE;INJECTION 065448 ANDA Athenex Pharmaceutical Division, LLC. 70860-127 70860-127-51 1 VIAL in 1 CARTON (70860-127-51) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5,000,000 UNITS/VIAL
Approval Date:Aug 18, 2009TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20,000,000 UNITS/VIAL
Approval Date:Aug 18, 2009TE:APRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.