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Generated: September 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021648

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NDA 021648 describes DIGOXIN, which is a drug marketed by Hikma Intl Pharms, Hospira, Abraxis Pharm, West-ward Pharms Int, Impax Labs, Sun Pharm Inds Inc, Stevens J, Sandoz Inc, Mylan Pharms Inc, and Wyeth Ayerst, 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for NDA: 021648

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

Pharmacology for NDA: 021648

Ingredient-typeCardiac Glycosides

Suppliers and Packaging for NDA: 021648

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIGOXIN
digoxin
ELIXIR;ORAL 021648 NDA West-Ward Pharmaceuticals Corp. 0054-0057 0054-0057-46 60 mL in 1 BOTTLE, DROPPER (0054-0057-46)
DIGOXIN
digoxin
ELIXIR;ORAL 021648 NDA Atlantic Biologicals Corps 17856-0057 17856-0057-1 2.5 mL in 1 CUP, UNIT-DOSE (17856-0057-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:ELIXIR;ORALStrength0.05MG/ML
Approval Date:Aug 26, 2004TE:RLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Healthtrust
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Julphar
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McKinsey
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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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