Details for New Drug Application (NDA): 021537
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NDA 021537 describes CIPRODEX, which is a drug marketed by Sandoz and is included in one NDA. It is available from five suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the CIPRODEX profile page.
The generic ingredient in CIPRODEX is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
The generic ingredient in CIPRODEX is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
Summary for 021537
| Tradename: | CIPRODEX |
| Applicant: | Sandoz |
| Ingredient: | ciprofloxacin; dexamethasone |
| Patents: | 1 |
Pharmacology for NDA: 021537
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 021537
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537 | NDA | Novartis Pharmaceuticals Corporation | 0078-0799 | 0078-0799-75 | 1 BOTTLE in 1 CARTON (0078-0799-75) / 7.5 mL in 1 BOTTLE |
| CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-6186 | 0781-6186-67 | 1 BOTTLE, DROPPER in 1 CARTON (0781-6186-67) / 7.5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OTIC | Strength | 0.3%;0.1% | ||||
| Approval Date: | Jul 18, 2003 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 4, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ACUTE OTITIS MEDIA | ||||||||
Expired US Patents for NDA 021537
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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