Application 077038
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 002 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
| 003 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 40MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54458-889 | CITALOPRAM | CITALOPRAM | International Laboratories, LLC | ANDA | Current |
| 54458-889 | CITALOPRAM | CITALOPRAM | International Laboratories, LLC | ANDA | Current |
| 54458-980 | CITALOPRAM | CITALOPRAM | International Laboratories, LLC | ANDA | Current |
| 54458-980 | CITALOPRAM | CITALOPRAM | International Laboratories, LLC | ANDA | Current |
| 54458-981 | CITALOPRAM | CITALOPRAM | International Laboratories, LLC | ANDA | Current |
| 54458-981 | CITALOPRAM | CITALOPRAM | International Laboratories, LLC | ANDA | Current |
| 55111-342 | Citalopram Hydrobromide | Citalopram Hydrobromide | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-342 | Citalopram Hydrobromide | Citalopram Hydrobromide | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-342 | Citalopram Hydrobromide | Citalopram Hydrobromide | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-343 | Citalopram Hydrobromide | Citalopram Hydrobromide | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-343 | Citalopram Hydrobromide | Citalopram Hydrobromide | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-343 | Citalopram Hydrobromide | Citalopram Hydrobromide | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-344 | Citalopram Hydrobromide | Citalopram Hydrobromide | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-344 | Citalopram Hydrobromide | Citalopram Hydrobromide | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-344 | Citalopram Hydrobromide | Citalopram Hydrobromide | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 66116-352 | Citalopram Hydrobromide | Citalopram Hydrobromide | MedVantx, Inc. | ANDA | Current |
| 66116-353 | Citalopram Hydrobromide | Citalopram Hydrobromide | MedVantx, Inc. | ANDA | Current |
| 66116-390 | Citalopram Hydrobromide | Citalopram Hydrobromide | MedVantx, Inc. | ANDA | Current |
| 68645-282 | Citalopram hydrobromide | Citalopram hydrobromide | Legacy Pharmaceutical Packaging | ANDA | Current |
| 68645-569 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-569 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-569 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-569 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-570 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-570 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-570 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-570 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-571 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-571 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-571 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-571 | Citalopram Hydrobromide | Citalopram Hydrobromide | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 70518-3502 | Citalopram Hydrobromide | Citalopram Hydrobromide | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44332 | ORIG | 2005-07-29 |
| 8997 | ORIG | 2004-10-29 |