Application 075909
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 5MG;12.5MG | No | No |
| 002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 10MG;25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55111-133 | Enalapril maleate and hydrochlorothiazide | Enalapril maleate and hydrochlorothiazide | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-134 | Enalapril maleate and hydrochlorothiazide | Enalapril maleate and hydrochlorothiazide | Dr. Reddy's Laboratories Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39497 | ORIG | 2004-06-03 |
| 43032 | ORIG | 2003-08-04 |
| 8828 | ORIG | 2003-04-17 |