| Product NDC: | 43386-551 |
| Proprietary Name: | Tinidazole |
| Non Proprietary Name: | Tinidazole |
| Active Ingredient(s): | 500 mg/1 & nbsp; Tinidazole |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 43386-551 |
| Labeler Name: | Gavis Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA202044 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120430 |
| Package NDC: | 43386-551-02 |
| Package Description: | 20 TABLET in 1 BOTTLE (43386-551-02) |
| NDC Code | 43386-551-02 |
| Proprietary Name | Tinidazole |
| Package Description | 20 TABLET in 1 BOTTLE (43386-551-02) |
| Product NDC | 43386-551 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Tinidazole |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20120430 |
| Marketing Category Name | ANDA |
| Labeler Name | Gavis Pharmaceuticals, LLC |
| Substance Name | TINIDAZOLE |
| Strength Number | 500 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] |