Details for New Drug Application (NDA): 206242
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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 206242
Tradename: | MOXIFLOXACIN HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | moxifloxacin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206242
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 206242 | ANDA | NorthStar Rx LLC | 16714-643 | 16714-643-01 | 1 BOTTLE in 1 CARTON (16714-643-01) / 3 mL in 1 BOTTLE |
MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 206242 | ANDA | Aurobindo Pharma Limited | 65862-840 | 65862-840-03 | 1 BOTTLE in 1 CARTON (65862-840-03) / 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: | Oct 4, 2017 | TE: | AT1 | RLD: | No |
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