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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020805

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NDA 020805 describes CIPRO HC, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from three suppliers. Additional details are available on the CIPRO HC profile page.

The generic ingredient in CIPRO HC is ciprofloxacin hydrochloride; hydrocortisone. There are thirty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; hydrocortisone profile page.

Summary for 020805

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020805

Ingredient-typeQuinolones
Mechanism of ActionCorticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 020805

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPRO HC ciprofloxacin hydrochloride; hydrocortisone SUSPENSION/DROPS;OTIC 020805 NDA Alcon Laboratories, Inc. 0065-8531 0065-8531-10 10 mL in 1 BOTTLE, GLASS (0065-8531-10)
CIPRO HC ciprofloxacin hydrochloride; hydrocortisone SUSPENSION/DROPS;OTIC 020805 NDA Stat Rx USA 16590-053 16590-053-10 10 mL in 1 BOTTLE, GLASS (16590-053-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OTICStrengthEQ 0.2% BASE;1%
Approval Date:Feb 10, 1998TE:RLD:Yes

Expired Orange Book Patents for NDA: 020805

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms CorpCIPRO HCciprofloxacin hydrochloride; hydrocortisoneSUSPENSION/DROPS;OTIC020805-001Feb 10, 1998► Subscribe► Subscribe
Novartis Pharms CorpCIPRO HCciprofloxacin hydrochloride; hydrocortisoneSUSPENSION/DROPS;OTIC020805-001Feb 10, 1998► Subscribe► Subscribe
Novartis Pharms CorpCIPRO HCciprofloxacin hydrochloride; hydrocortisoneSUSPENSION/DROPS;OTIC020805-001Feb 10, 1998► Subscribe► Subscribe
Novartis Pharms CorpCIPRO HCciprofloxacin hydrochloride; hydrocortisoneSUSPENSION/DROPS;OTIC020805-001Feb 10, 1998► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Teva
Chinese Patent Office
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Fuji
US Army
Citi
Fish and Richardson
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