Details for New Drug Application (NDA): 216755
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The generic ingredient in LIKMEZ is metronidazole. There are eighteen drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 216755
Tradename: | LIKMEZ |
Applicant: | Saptalis Pharms |
Ingredient: | metronidazole |
Patents: | 1 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216755
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIKMEZ | metronidazole | SUSPENSION;ORAL | 216755 | NDA | Saptalis Pharmaceuticals, LLC | 71656-066 | 71656-066-20 | 200 mL in 1 BOTTLE (71656-066-20) |
LIKMEZ | metronidazole | SUSPENSION;ORAL | 216755 | NDA | Kesin Pharma Corporation | 81033-066 | 81033-066-20 | 200 mL in 1 BOTTLE (81033-066-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 500MG/5ML | ||||
Approval Date: | Sep 22, 2023 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 4, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? |
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