Details for New Drug Application (NDA): 020805

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NDA 020805 describes CIPRO HC, which is a drug marketed by Sandoz 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-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; hydrocortisone profile page.

Summary for 020805

Tradename:	CIPRO HC
Applicant:	Sandoz
Ingredient:	ciprofloxacin hydrochloride; hydrocortisone
Patents:	0

Pharmacology for NDA: 020805

Mechanism of Action	Corticosteroid Hormone Receptor Agonists Cytochrome P450 1A2 Inhibitors

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	A-S Medication Solutions	50090-6043	50090-6043-0	10 mL in 1 BOTTLE (50090-6043-0)
CIPRO HC	ciprofloxacin hydrochloride; hydrocortisone	SUSPENSION/DROPS;OTIC	020805	NDA	A-S Medication Solutions	50090-7631	50090-7631-0	1 BOTTLE in 1 CARTON (50090-7631-0) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OTIC			Strength	EQ 0.2% BASE;1%
Approval Date:	Feb 10, 1998	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020805

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	CIPRO HC	ciprofloxacin hydrochloride; hydrocortisone	SUSPENSION/DROPS;OTIC	020805-001	Feb 10, 1998	4,670,444*PED	⤷ Get Started Free
Sandoz	CIPRO HC	ciprofloxacin hydrochloride; hydrocortisone	SUSPENSION/DROPS;OTIC	020805-001	Feb 10, 1998	5,965,549	⤷ Get Started Free
Sandoz	CIPRO HC	ciprofloxacin hydrochloride; hydrocortisone	SUSPENSION/DROPS;OTIC	020805-001	Feb 10, 1998	5,843,930	⤷ Get Started Free
Sandoz	CIPRO HC	ciprofloxacin hydrochloride; hydrocortisone	SUSPENSION/DROPS;OTIC	020805-001	Feb 10, 1998	4,844,902*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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