Details for New Drug Application (NDA): 200563
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The generic ingredient in CIPROFLOXACIN is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-five 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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