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Pylera
Pylera - 58914-600-21 - (Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride)
Drug Information of Pylera
| Product NDC: | 58914-600 |
| Proprietary Name: | Pylera |
| Non Proprietary Name: | Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride |
| Active Ingredient(s): | 140; 125; 125 mg/1; mg/1; mg/1 & nbsp; Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Pylera
| Product NDC: | 58914-600 |
| Labeler Name: | Aptalis Pharma US, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA050786 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20070501 |
Package Information of Pylera
| Package NDC: | 58914-600-21 |
| Package Description: | 1 BOTTLE in 1 BOX (58914-600-21) > 120 CAPSULE in 1 BOTTLE |
NDC Information of Pylera
| NDC Code | 58914-600-21 |
| Proprietary Name | Pylera |
| Package Description | 1 BOTTLE in 1 BOX (58914-600-21) > 120 CAPSULE in 1 BOTTLE |
| Product NDC | 58914-600 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20070501 |
| Marketing Category Name | NDA |
| Labeler Name | Aptalis Pharma US, Inc. |
| Substance Name | BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
| Strength Number | 140; 125; 125 |
| Strength Unit | mg/1; mg/1; mg/1 |
| Pharmaceutical Classes | Bismuth [Chemical/Ingredient],Bismuth [EPC],Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient],Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] |
