| NDC Code | 58487-001-02 |
|---|
| Package Description | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58487-001-02) |
|---|
| Product NDC | 58487-001 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Durlaza |
|---|
| Non-Proprietary Name | Acetylsalicylic Acid |
|---|
| Dosage Form | CAPSULE, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20150925 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA200671 |
|---|
| Manufacturer | New Haven Pharmaceuticals, Inc. |
|---|
| Substance Name | ASPIRIN |
|---|
| Strength | 162.5 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] |
|---|