Details for New Drug Application (NDA): 020780
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NDA 020780 describes CIPRO, which is a drug marketed by Bayer Hlthcare, Sandoz, Bayer Pharms, Chartwell, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Sentiss, Sun Pharm, Ani Pharms, Dr Reddys Labs Ltd, Endo Operations, Fosun Pharma, Rising, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rubicon, Sciegen Pharms Inc, The J Molner, Watson Labs Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in sixty NDAs. It is available from one supplier. There is one patent 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. Ten 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. Ten 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 |
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, PLASTIC * 100 mL in 1 BOTTLE, GLASS |
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 | 020780-002 | 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 | 020780-001 | Sep 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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