Details for New Drug Application (NDA): 205223
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NDA 205223 describes NUVESSA, which is a drug marketed by Chemo Research Sl and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the NUVESSA profile page.
The generic ingredient in NUVESSA is metronidazole. There are eighteen drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
The generic ingredient in NUVESSA is metronidazole. There are eighteen drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 205223
| Tradename: | NUVESSA |
| Applicant: | Chemo Research Sl |
| Ingredient: | metronidazole |
| Patents: | 7 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205223
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NUVESSA | metronidazole | GEL;VAGINAL | 205223 | NDA | Exeltis USA, Inc. | 0642-7466 | 0642-7466-05 | 1 APPLICATOR in 1 CARTON (0642-7466-05) / 5 g in 1 APPLICATOR |
| NUVESSA | metronidazole | GEL;VAGINAL | 205223 | NDA | Exeltis USA, Inc. | 0642-7466 | 0642-7466-06 | 1 APPLICATOR in 1 CARTON (0642-7466-06) / 5 g in 1 APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;VAGINAL | Strength | 1.3% | ||||
| Approval Date: | Mar 24, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 19, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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