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Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078031

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NDA 078031 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, Anda Repository, Exela Holdings, and Actavis Labs Fl Inc, and is included in forty-three NDAs. It is available from seventy-nine 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. Seventeen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

Summary for 078031

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: 078031

Suppliers and Packaging for NDA: 078031

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC 078031 ANDA Sandoz Inc 61314-014 61314-014-05 5 mL in 1 BOTTLE (61314-014-05)
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC 078031 ANDA Sandoz Inc 61314-014 61314-014-25 2.5 mL in 1 BOTTLE (61314-014-25)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Feb 6, 2008TE:ATRLD:No


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Serving leading biopharmaceutical companies globally:

QuintilesIMS
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US Army
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Harvard Business School
Dow
Julphar
Cipla
Fuji

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