Product NDC: | 0955-1040 |
Proprietary Name: | Irbesartan |
Non Proprietary Name: | Irbesartan |
Active Ingredient(s): | 75 mg/1 & nbsp; Irbesartan |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0955-1040 |
Labeler Name: | Winthrop U.S. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020757 |
Marketing Category: | NDA |
Start Marketing Date: | 20120301 |
Package NDC: | 0955-1040-30 |
Package Description: | 30 TABLET, FILM COATED in 1 BOTTLE (0955-1040-30) |
NDC Code | 0955-1040-30 |
Proprietary Name | Irbesartan |
Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (0955-1040-30) |
Product NDC | 0955-1040 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Irbesartan |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20120301 |
Marketing Category Name | NDA |
Labeler Name | Winthrop U.S. |
Substance Name | IRBESARTAN |
Strength Number | 75 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] |