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Details for New Drug Application (NDA): 075463

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NDA 075463 describes DICLOFENAC POTASSIUM, which is a drug marketed by Teva, Sandoz, Bionpharma Inc, Watson Labs, Apotex, Mylan, Par Form, and Sun Pharm Inds, and is included in nine NDAs. It is available from nineteen suppliers. Additional details are available on the DICLOFENAC POTASSIUM profile page.

The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

Summary for NDA: 075463

Tradename:
DICLOFENAC POTASSIUM
Applicant:
Mylan
Ingredient:
diclofenac potassium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075463

Suppliers and Packaging for NDA: 075463

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC POTASSIUM
diclofenac potassium
TABLET;ORAL 075463 ANDA Mylan Pharmaceuticals Inc. 0378-2474 0378-2474-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2474-01)
DICLOFENAC POTASSIUM
diclofenac potassium
TABLET;ORAL 075463 ANDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 49999-593 49999-593-20 20 TABLET, FILM COATED in 1 BOTTLE (49999-593-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 26, 1999TE:ABRLD:Yes


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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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