Details for New Drug Application (NDA): 075593
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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-four suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 075593
Tradename: | CIPROFLOXACIN HYDROCHLORIDE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | ciprofloxacin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075593
Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 075593
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075593 | ANDA | Major Pharmaceuticals | 0904-6378 | 0904-6378-61 | 100 BLISTER PACK in 1 CARTON (0904-6378-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075593 | ANDA | Quality Care Products, LLC | 35356-733 | 35356-733-06 | 6 TABLET, FILM COATED in 1 BOTTLE (35356-733-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 750MG BASE | ||||
Approval Date: | Jun 9, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Jun 9, 2004 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Jun 9, 2004 | TE: | AB | RLD: | No |
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