Application 076007
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 12.5MG;10MG | No | No |
| 002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 12.5MG;20MG | No | No |
| 003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 25MG;20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63304-536 | Lisinopril and Hydrochlorothiazide | Lisinopril and hydrochlorothiazide | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-537 | Lisinopril and Hydrochlorothiazide | Lisinopril and hydrochlorothiazide | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-538 | Lisinopril and Hydrochlorothiazide | Lisinopril and hydrochlorothiazide | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31060 | ORIG | 2004-06-08 |
| 8848 | ORIG | 2003-04-10 |