Details for New Drug Application (NDA): 202044
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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 202044
Tradename: | TINIDAZOLE |
Applicant: | Chartwell Rx |
Ingredient: | tinidazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 202044
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TINIDAZOLE | tinidazole | TABLET;ORAL | 202044 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-550 | 43386-550-04 | 40 TABLET in 1 BOTTLE (43386-550-04) |
TINIDAZOLE | tinidazole | TABLET;ORAL | 202044 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-551 | 43386-551-02 | 20 TABLET in 1 BOTTLE (43386-551-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Apr 30, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Apr 30, 2012 | TE: | AB | RLD: | No |
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