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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075492

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NDA 075492 describes DICLOFENAC SODIUM, which is a drug marketed by Apotex Inc, Glenmark Pharms Ltd, Dexcel Ltd, Falcon Pharms, Actavis Elizabeth, Riconpharma Llc, Amneal Pharms, Taro, Teva, Sandoz Inc, Lupin Ltd, Pliva, Tolmar, Actavis Labs Ut Inc, Akorn, Watson Labs Inc, Mylan, Rising Pharms Inc, Teva Pharms, Unique Pharm Labs, Teligent Pharma Inc, Sandoz, Novel Labs Inc, Mylan Pharms Inc, Altaire Pharms Inc, Carlsbad, Allied Pharma Inc, Roxane, Bausch And Lomb, Vpna, Actavis Mid Atlantic, Twi Pharms Inc, Exela Holdings, and Actavis Labs Fl Inc, and is included in forty-three NDAs. It is available from seventy-three suppliers. Additional details are available on the DICLOFENAC SODIUM profile page.

The generic ingredient in DICLOFENAC SODIUM is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

Summary for NDA: 075492

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075492

Suppliers and Packaging for NDA: 075492

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM
diclofenac sodium
TABLET, EXTENDED RELEASE;ORAL 075492 ANDA TEVA Pharmaceuticals USA Inc. 0093-1041 0093-1041-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1041-01)
DICLOFENAC SODIUM
diclofenac sodium
TABLET, EXTENDED RELEASE;ORAL 075492 ANDA Oceanside Pharmaceuticals 68682-103 68682-103-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-103-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Feb 11, 2000TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Argus Health
US Army
Covington
Express Scripts
Chinese Patent Office
Medtronic
Julphar
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Johnson and Johnson

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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