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Details for New Drug Application (NDA): 062981

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NDA 062981 describes PENICILLIN V POTASSIUM, which is a drug marketed by Ivax Sub Teva Pharms, Mylan, Am Antibiotics, Aurobindo Pharma, Dava Pharms Inc, Hikma Pharms, Purepac Pharm, and Sandoz, and is included in thirteen NDAs. It is available from twenty-five 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-seven suppliers are listed for this compound. Additional details are available on the penicillin v potassium profile page.

Summary for NDA: 062981

Tradename:
PENICILLIN V POTASSIUM
Applicant:
Dava Pharms Inc
Ingredient:
penicillin v potassium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 062981

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 062981

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENICILLIN V POTASSIUM
penicillin v potassium
FOR SOLUTION;ORAL 062981 ANDA DAVA Pharmaceuticals, Inc. 67253-202 67253-202-10 100 mL in 1 BOTTLE (67253-202-10)
PENICILLIN V POTASSIUM
penicillin v potassium
FOR SOLUTION;ORAL 062981 ANDA DAVA Pharmaceuticals, Inc. 67253-202 67253-202-20 200 mL in 1 BOTTLE (67253-202-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 125MG BASE/5ML
Approval Date:Feb 10, 1989TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Feb 10, 1989TE:AARLD:No


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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 verifification 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.

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