Details for New Drug Application (NDA): 090080
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NDA 090080 describes MOXIFLOXACIN HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland, Lupin Ltd, Mankind Pharma, Pharmobedient, Regcon Holdings, Somerset Theraps Llc, 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-five NDAs. It is available from thirty 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-three 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-three suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 090080
| Tradename: | MOXIFLOXACIN HYDROCHLORIDE |
| Applicant: | Apotex |
| Ingredient: | moxifloxacin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090080
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 090080 | ANDA | Golden State Medical Supply, Inc. | 51407-321 | 51407-321-03 | 1 BOTTLE, DROPPER in 1 CARTON (51407-321-03) / 3 mL in 1 BOTTLE, DROPPER |
| MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 090080 | ANDA | Apotex Corp. | 60505-0582 | 60505-0582-4 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0582-4) / 3 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE | ||||
| Approval Date: | Jun 30, 2017 | TE: | AT1 | RLD: | No | ||||
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