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Details for New Drug Application (NDA): 019992

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NDA 019992 describes CILOXAN, which is a drug marketed by Alcon Pharms Ltd and is included in two NDAs. It is available from six suppliers. Additional details are available on the CILOXAN profile page.

The generic ingredient in CILOXAN is ciprofloxacin hydrochloride. There are thirty-one drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for NDA: 019992

Tradename:
CILOXAN
Applicant:
Alcon Pharms Ltd
Ingredient:
ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 019992

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 019992

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CILOXAN
ciprofloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC 019992 NDA Alcon Laboratories, Inc. 0065-0656 0065-0656-05 1 BOTTLE, PLASTIC in 1 CARTON (0065-0656-05) > 5 mL in 1 BOTTLE, PLASTIC
CILOXAN
ciprofloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC 019992 NDA Alcon Laboratories, Inc. 0065-0656 0065-0656-10 1 BOTTLE, PLASTIC in 1 CARTON (0065-0656-10) > 10 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.3% BASE
Approval Date:Dec 31, 1990TE:ATRLD:Yes

Expired Orange Book Patents for NDA: 019992

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon Pharms Ltd
CILOXAN
ciprofloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC019992-001Dec 31, 19904,670,444*PED► subscribe
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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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