Application 204760
- Type
- NDA
- Sponsor
- ASTRAZENECA PHARMS
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MOVANTIK | NALOXEGOL OXALATE | TABLET;ORAL | EQ 12.5MG BASE | Yes | No |
| 002 | MOVANTIK | NALOXEGOL OXALATE | TABLET;ORAL | EQ 25MG BASE | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0310-1969 | MOVANTIK | naloxegol oxalate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1969 | MOVANTIK | naloxegol oxalate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1969 | MOVANTIK | naloxegol oxalate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1969 | MOVANTIK | naloxegol oxalate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1970 | MOVANTIK | naloxegol oxalate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1970 | MOVANTIK | naloxegol oxalate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1970 | MOVANTIK | naloxegol oxalate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1970 | MOVANTIK | naloxegol oxalate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 55700-383 | MOVANTIK | naloxegol oxalate | Quality Care Products, LLC | NDA | Current |
| 55700-383 | MOVANTIK | naloxegol oxalate | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 55700-383 | MOVANTIK | naloxegol oxalate | Quality Care Products, LLC | NDA | Current |
| 55700-988 | MOVANTIK | naloxegol oxalate | Quality Care Products, LLC | NDA | Current |
| 57841-1300 | MOVANTIK | naloxegol oxalate | RedHill Biopharma Ltd | NDA | Current |
| 57841-1300 | MOVANTIK | naloxegol oxalate | RedHill Biopharma Ltd | NDA | Current |
| 57841-1300 | MOVANTIK | naloxegol oxalate | RedHill Biopharma Ltd | NDA | Current |
| 57841-1301 | MOVANTIK | naloxegol oxalate | RedHill Biopharma Ltd | NDA | Current |
| 57841-1301 | MOVANTIK | naloxegol oxalate | RedHill Biopharma Ltd | NDA | Current |
| 57841-1301 | MOVANTIK | naloxegol oxalate | RedHill Biopharma Ltd | NDA | Current |