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Application 077512
- Type
- ANDA
- Sponsor
- PHARM ASSOC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54879-009 | escitalopram | escitalopram | STI Pharma LLC | ANDA | Current |
| 54879-010 | escitalopram | escitalopram | STI Pharma LLC | ANDA | Current |
| 54879-011 | escitalopram | escitalopram | STI Pharma LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31254 | ORIG | 2011-05-10 |