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Details for New Drug Application (NDA): 020780
NDA 020780 describes CIPRO, which is a drug marketed by Bayer Hlthcare, Novartis Pharms Corp, Bayer Pharms, Lupin Ltd, Baxter Hlthcare Corp, Bedford Labs, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Mylan Pharms Inc, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Apotex Inc, Fdc Ltd, Rising Pharms, Teligent, Watson Labs Inc, Ani Pharms Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, Watson Labs, Yiling Pharm Ltd, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in fifty-seven NDAs. It is available from one supplier. There are eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the CIPRO profile page.
The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty-one drug master file entries for this compound. Three 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 |
| 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 | 50419-773-01 | 1 KIT in 1 KIT (50419-773-01) * 100 mL in 1 BOTTLE, GLASS * 100 mL in 1 BOTTLE, GLASS |
| CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-777 | 50419-777-01 | 1 KIT in 1 KIT (50419-777-01) * 100 mL in 1 BOTTLE, GLASS * 100 mL in 1 BOTTLE, PLASTIC |
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 | 020780-002 | 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 | 020780-001 | 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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