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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Daiichi Sankyo
Chinese Patent Office
Cerilliant
QuintilesIMS
Covington
Johnson and Johnson
Healthtrust
Julphar

Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074394

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NDA 074394 describes DICLOFENAC SODIUM, which is a drug marketed by Apotex Inc, Glenmark Pharms Ltd, Dexcel Ltd, Falcon Pharms, Actavis Elizabeth, 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-two NDAs. It is available from seventy-two 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: 074394

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: 074394

Suppliers and Packaging for NDA: 074394

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL 074394 ANDA Sandoz Inc 0781-1789 0781-1789-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0781-1789-01)
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL 074394 ANDA Sandoz Inc 0781-1789 0781-1789-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (0781-1789-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength75MG
Approval Date:Nov 30, 1995TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Colorcon
Citi
Johnson and Johnson
Federal Trade Commission
Daiichi Sankyo
Deloitte
Fuji
Chubb
Express Scripts
US Department of Justice

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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