Application 077812
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | SOLUTION;ORAL | EQ 10MG BASE/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57237-148 | Citalopram Hydrobromide | Citalopram Hydrobromide | Citron Pharma LLC | ANDA | Current |
| 65862-074 | Citalopram Hydrobromide | Citalopram Hydrobromide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-074 | Citalopram Hydrobromide | Citalopram Hydrobromide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-074 | Citalopram Hydrobromide | Citalopram Hydrobromide | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44364 | ORIG | 2006-09-12 |