Details for New Drug Application (NDA): 206447
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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 206447
Tradename: | MOXIFLOXACIN HYDROCHLORIDE |
Applicant: | Mylan |
Ingredient: | moxifloxacin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206447
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 206447 | ANDA | Mylan Pharmaceuticals Inc. | 0378-5430 | 0378-5430-35 | 1 BOTTLE in 1 CARTON (0378-5430-35) / 3 mL in 1 BOTTLE |
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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