Details for New Drug Application (NDA): 020805
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The generic ingredient in CIPRO HC is ciprofloxacin hydrochloride; hydrocortisone. There are thirty-four 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: | 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 | Novartis Pharmaceuticals Corporation | 0078-0855 | 0078-0855-26 | 10 mL in 1 BOTTLE (0078-0855-26) |
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) |
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: | RLD: | Yes |
Expired US Patents for NDA 020805
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | CIPRO HC | ciprofloxacin hydrochloride; hydrocortisone | SUSPENSION/DROPS;OTIC | 020805-001 | Feb 10, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | CIPRO HC | ciprofloxacin hydrochloride; hydrocortisone | SUSPENSION/DROPS;OTIC | 020805-001 | Feb 10, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | CIPRO HC | ciprofloxacin hydrochloride; hydrocortisone | SUSPENSION/DROPS;OTIC | 020805-001 | Feb 10, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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