Details for New Drug Application (NDA): 205572
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NDA 205572 describes MOXIFLOXACIN HYDROCHLORIDE, which is a drug marketed by Adaptis, Alembic, Apotex, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Lupin Ltd, Mylan, Upsher Smith Labs, Fresenius Kabi Usa, Aurobindo Pharma Ltd, Chartwell Rx, Crossmedika Sa, Dr Reddys, Hetero Labs Ltd V, MSN, Natco, Sunshine, Teva Pharms Usa, Torrent, and Mylan Labs Ltd, and is included in twenty-two NDAs. It is available from thirty-one suppliers. Additional details are available on the MOXIFLOXACIN HYDROCHLORIDE profile page.
The generic ingredient in MOXIFLOXACIN HYDROCHLORIDE is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
The generic ingredient in MOXIFLOXACIN HYDROCHLORIDE is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 205572
| Tradename: | MOXIFLOXACIN HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | moxifloxacin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205572
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION;INTRAVENOUS | 205572 | NDA | Fresenius Kabi USA, LLC | 63323-850 | 63323-850-04 | 12 BAG in 1 CASE (63323-850-04) / 250 mL in 1 BAG (63323-850-74) |
| MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION;INTRAVENOUS | 205572 | NDA | Hp Halden Pharma AS | 66298-8507 | 66298-8507-4 | 250 mL in 1 BAG (66298-8507-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML) | ||||
| Approval Date: | Apr 3, 2015 | TE: | RLD: | Yes | |||||
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