Details for New Drug Application (NDA): 208778
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NDA 208778 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 208778
| Tradename: | MOXIFLOXACIN HYDROCHLORIDE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | moxifloxacin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208778
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 208778 | ANDA | A-S Medication Solutions | 50090-6248 | 50090-6248-0 | 1 BOTTLE in 1 CARTON (50090-6248-0) / 3 mL in 1 BOTTLE |
| MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 208778 | ANDA | Gland Pharma Limited | 68083-210 | 68083-210-01 | 1 BOTTLE, PLASTIC in 1 CARTON (68083-210-01) / 3 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE | ||||
| Approval Date: | Mar 30, 2020 | TE: | AT1 | RLD: | No | ||||
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