DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 077782
NDA 077782 describes CIPROFLOXACIN, which is a drug marketed by Lupin Ltd, Baxter Hlthcare Corp, Bedford Labs, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Mylan Pharms Inc, Akorn Inc, Amring Pharms, Apotex Inc, Fdc Ltd, Rising Pharms Inc, Teligent, Watson Labs Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Hikma, Idt Australia Ltd, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, Watson Labs, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in forty-seven NDAs. It is available from four suppliers. Additional details are available on the CIPROFLOXACIN profile page.
The generic ingredient in CIPROFLOXACIN is ciprofloxacin hydrochloride. There are thirty-one drug master file entries for this compound. Seventy-three 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-one drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 077782
| Tradename: | CIPROFLOXACIN |
| Applicant: | Teva Pharms Usa |
| Ingredient: | ciprofloxacin |
| Patents: | 0 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077782
| Ingredient-type | Quinolones |
Medical Subject Heading (MeSH) Categories for 077782
Suppliers and Packaging for NDA: 077782
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN | ciprofloxacin | INJECTABLE;INJECTION | 077782 | ANDA | Rebel Distributors Corp | 21695-422 | E | 21695-422-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/20ML (10MG/ML) | ||||
| Approval Date: | Aug 28, 2006 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 400MG/40ML (10MG/ML) | ||||
| Approval Date: | Aug 28, 2006 | TE: | RLD: | No | |||||
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