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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 four 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. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; hydrocortisone profile page.

Summary for NDA: 020805

Tradename:
CIPRO HC
Applicant:
Novartis Pharms Corp
Ingredient:
ciprofloxacin hydrochloride; hydrocortisone
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 Corp
CIPRO HC
ciprofloxacin hydrochloride; hydrocortisone
SUSPENSION/DROPS;OTIC020805-001Feb 10, 19984,670,444*PED► subscribe
Novartis Pharms Corp
CIPRO HC
ciprofloxacin hydrochloride; hydrocortisone
SUSPENSION/DROPS;OTIC020805-001Feb 10, 19985,965,549► subscribe
Novartis Pharms Corp
CIPRO HC
ciprofloxacin hydrochloride; hydrocortisone
SUSPENSION/DROPS;OTIC020805-001Feb 10, 19984,844,902*PED► subscribe
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