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Details for New Drug Application (NDA): 020780
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NDA 020780 describes CIPRO, which is a drug marketed by Bayer Hlthcare, Novartis, Bayer Pharms, Chartwell, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Dr Reddys Labs Ltd, Anchen Pharms, Ani Pharms Inc, Fosun Pharma, Mylan Pharms Inc, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique Pharm Labs, Watson Labs, Yiling, 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-four drug master file entries for this compound. Four 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-four drug master file entries for this compound. Four 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 |
Paragraph IV (Patent) Challenges for 020780
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CIPRO | FOR SUSPENSION;ORAL | ciprofloxacin | 020780 | 2009-10-16 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
| Approval Date: | Sep 26, 1997 | TE: | 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: | 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 | Start Trial | Start Trial |
| Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-001 | Sep 26, 1997 | Start Trial | Start Trial |
| Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-001 | Sep 26, 1997 | Start Trial | Start Trial |
| Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-002 | Sep 26, 1997 | Start Trial | Start Trial |
| Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-002 | Sep 26, 1997 | Start Trial | Start Trial |
| Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-001 | Sep 26, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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