Details for New Drug Application (NDA): 020208
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The generic ingredient in METROGEL-VAGINAL 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 020208
| Tradename: | METROGEL-VAGINAL |
| Applicant: | Bausch |
| Ingredient: | metronidazole |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020208
Suppliers and Packaging for NDA: 020208
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208 | NDA AUTHORIZED GENERIC | A-S Medication Solutions | 50090-2126 | 50090-2126-0 | 70 g in 1 TUBE, WITH APPLICATOR (50090-2126-0) |
| METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-455 | 68682-455-70 | 1 TUBE, WITH APPLICATOR in 1 CARTON (68682-455-70) / 70 g in 1 TUBE, WITH APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | GEL;VAGINAL | Strength | 0.75% | ||||
| Approval Date: | Aug 17, 1992 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020208
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | 4,837,378 | ⤷ Get Started Free |
| Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | 5,840,744 | ⤷ Get Started Free |
| Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | 5,536,743 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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