Application 078777
- Type
- ANDA
- Sponsor
- GRAVITI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 002 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 003 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | TABLET;ORAL | EQ 20MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50436-0054 | Escitalopram | Escitalopram Oxalate | Unit Dose Services | ANDA | Current |
| 69844-033 | ESCITALOPRAM | ESCITALOPRAM OXALATE | Graviti Pharmaceuticals Private Limited | ANDA | Current |
| 69844-034 | ESCITALOPRAM | ESCITALOPRAM OXALATE | Graviti Pharmaceuticals Private Limited | ANDA | Current |
| 69844-035 | ESCITALOPRAM | ESCITALOPRAM OXALATE | Graviti Pharmaceuticals Private Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31388 | ORIG | 2011-05-10 |