Details for New Drug Application (NDA): 208921
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The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE 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 208921
Tradename: | CIPROFLOXACIN HYDROCHLORIDE |
Applicant: | Yiling |
Ingredient: | ciprofloxacin hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 208921
Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 208921
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 208921 | ANDA | Solco Healthcare US, LLC | 43547-688 | 43547-688-10 | 100 TABLET in 1 BOTTLE (43547-688-10) |
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 208921 | ANDA | Solco Healthcare US, LLC | 43547-689 | 43547-689-10 | 100 TABLET in 1 BOTTLE (43547-689-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Jun 22, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Jun 22, 2018 | TE: | AB | RLD: | No |
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