Details for New Drug Application (NDA): 216755
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NDA 216755 describes LIKMEZ, which is a drug marketed by Saptalis Pharms and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the LIKMEZ profile page.
The generic ingredient in LIKMEZ is metronidazole. There are eighteen drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
The generic ingredient in LIKMEZ is metronidazole. There are eighteen drug master file entries for this compound. Seventy-three 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 |
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 | Saptalis Pharmaceuticals, LLC | 71656-066 | 71656-066-75 | 75 mL in 1 BOTTLE (71656-066-75) |
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: | 11,541,035 | Patent Expiration: | Oct 4, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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