Details for New Drug Application (NDA): 021618
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NDA 021618 describes TINDAMAX, which is a drug marketed by Mission Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the TINDAMAX profile page.
The generic ingredient in TINDAMAX is tinidazole. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tinidazole profile page.
The generic ingredient in TINDAMAX is tinidazole. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tinidazole profile page.
Summary for 021618
| Tradename: | TINDAMAX |
| Applicant: | Mission Pharma |
| Ingredient: | tinidazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021618
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TINDAMAX | tinidazole | TABLET;ORAL | 021618 | NDA | Mission Pharmacal Company | 0178-8250 | 0178-8250-40 | 40 TABLET, FILM COATED in 1 BOTTLE (0178-8250-40) |
| TINDAMAX | tinidazole | TABLET;ORAL | 021618 | NDA | Mission Pharmacal Company | 0178-8500 | 0178-8500-20 | 20 TABLET, FILM COATED in 1 BOTTLE (0178-8500-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | May 17, 2004 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | May 17, 2004 | TE: | AB | RLD: | Yes | ||||
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