Details for New Drug Application (NDA): 200563
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NDA 200563 describes CIPROFLOXACIN, which is a drug marketed by 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 fifty-two NDAs. It is available from one supplier. Additional details are available on the CIPROFLOXACIN profile page.
The generic ingredient in CIPROFLOXACIN is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
The generic ingredient in CIPROFLOXACIN is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 200563
| Tradename: | CIPROFLOXACIN |
| Applicant: | Chartwell |
| Ingredient: | ciprofloxacin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 200563
Suppliers and Packaging for NDA: 200563
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN | ciprofloxacin | FOR SUSPENSION;ORAL | 200563 | ANDA | Chartwell RX, LLC | 62135-392 | 62135-392-42 | 1 KIT in 1 KIT (62135-392-42) * 100 mL in 1 BOTTLE * 100 mL in 1 BOTTLE |
| CIPROFLOXACIN | ciprofloxacin | FOR SUSPENSION;ORAL | 200563 | ANDA | Chartwell RX, LLC | 62135-393 | 62135-393-42 | 1 KIT in 1 KIT (62135-393-42) * 100 mL in 1 BOTTLE * 100 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
| Approval Date: | Mar 5, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 500MG/5ML | ||||
| Approval Date: | Mar 5, 2014 | TE: | AB | RLD: | No | ||||
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