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Serving leading biopharmaceutical companies globally:

US Department of Justice
Fish and Richardson
Chinese Patent Office
Johnson and Johnson
Moodys
McKesson
AstraZeneca
Medtronic
Dow
Federal Trade Commission

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083391

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NDA 083391 describes DIGOXIN, which is a drug marketed by West-ward Pharms Int, Abraxis Pharm, Hospira, Sandoz Inc, Wyeth Ayerst, Hikma Intl Pharms, Impax Labs, Mylan Pharms Inc, Stevens J, and Sun Pharm Inds Inc, and is included in thirteen NDAs. It is available from thirty-two suppliers. Additional details are available on the DIGOXIN profile page.

The generic ingredient in DIGOXIN is digoxin. There are ten drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for 083391

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 083391

Ingredient-typeCardiac Glycosides

Medical Subject Heading (MeSH) Categories for 083391

Suppliers and Packaging for NDA: 083391

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIGOXIN digoxin INJECTABLE;INJECTION 083391 ANDA West-Ward Pharmaceuticals Corp. 0641-1410 0641-1410-35 25 AMPULE in 1 CARTON (0641-1410-35) > 2 mL in 1 AMPULE (0641-1410-31)
DIGOXIN digoxin INJECTABLE;INJECTION 083391 ANDA West-Ward Pharmaceuticals Corp. 0641-6184 0641-6184-25 25 AMPULE in 1 CARTON (0641-6184-25) > 2 mL in 1 AMPULE (0641-6184-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Covington
Farmers Insurance
Cantor Fitzgerald
Teva
QuintilesIMS
Moodys
Express Scripts
Cipla
Medtronic
US Army

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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