Details for New Drug Application (NDA): 202489
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The generic ingredient in TINIDAZOLE 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 202489
Tradename: | TINIDAZOLE |
Applicant: | Thinq Pharm-cro Pvt |
Ingredient: | tinidazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 202489
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TINIDAZOLE | tinidazole | TABLET;ORAL | 202489 | ANDA | Rising Pharma Holdings, Inc. | 64980-426 | 64980-426-02 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-426-02) |
TINIDAZOLE | tinidazole | TABLET;ORAL | 202489 | ANDA | Rising Pharma Holdings, Inc. | 64980-427 | 64980-427-12 | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Oct 9, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Oct 9, 2013 | TE: | AB | RLD: | No |
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