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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, Amneal Pharms, Taro, Teva, Alcon Pharms Ltd, Lupin Ltd, Pliva, Tolmar, 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, Nostrum Labs, Roxane, Bausch And Lomb, Vpna, Actavis Mid Atlantic, Paddock Llc, Exela Pharma Scs Llc, and Actavis Labs Fl Inc, and is included in forty NDAs. It is available from sixty-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. Eighteen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

Summary for NDA: 078031

Tradename:
DICLOFENAC SODIUM
Applicant:
Alcon Pharms Ltd
Ingredient:
diclofenac sodium
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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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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