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Details for New Drug Application (NDA): 020780
The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
Summary for 020780
Tradename: | CIPRO |
Applicant: | Bayer Hlthcare |
Ingredient: | ciprofloxacin |
Patents: | 0 |
Therapeutic Class: | Antibacterials |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 020780
Suppliers and Packaging for NDA: 020780
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-773 | N | 50419-773-01 |
CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-777 | N | 50419-777-01 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
Approval Date: | Sep 26, 1997 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 500MG/5ML | ||||
Approval Date: | Sep 26, 1997 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020780
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-001 | Sep 26, 1997 | ➤ Sign Up | ➤ Sign Up |
Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-002 | Sep 26, 1997 | ➤ Sign Up | ➤ Sign Up |
Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-001 | Sep 26, 1997 | ➤ Sign Up | ➤ Sign Up |
Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-002 | Sep 26, 1997 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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