Application 076470
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | TABLET;ORAL | 0.1MG | No | No |
| 002 | DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | TABLET;ORAL | 0.2MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-2464 | Desmopressin Acetate | Desmopressin Acetate | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2464 | Desmopressin Acetate | Desmopressin Acetate | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2465 | Desmopressin Acetate | Desmopressin Acetate | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2465 | Desmopressin Acetate | Desmopressin Acetate | Actavis Pharma, Inc. | ANDA | Current |
| 50268-220 | Desmopressin Acetate | Desmopressin Acetate | AvPAK | ANDA | Current |
| 50268-220 | Desmopressin Acetate | Desmopressin Acetate | AvPAK | ANDA | Current |
| 50268-221 | Desmopressin Acetate | Desmopressin Acetate | AvPAK | ANDA | Current |
| 50268-221 | Desmopressin Acetate | Desmopressin Acetate | AvPAK | ANDA | Current |
| 63629-4816 | Desmopressin Acetate | Desmopressin Acetate | Bryant Ranch Prepack | ANDA | Current |
| 68001-233 | Desmopressin Acetate | Desmopressin Acetate | BluePoint Laboratories | ANDA | Current |
| 68001-233 | Desmopressin Acetate | Desmopressin Acetate | BluePoint Laboratories | ANDA | Current |
| 68001-234 | Desmopressin Acetate | Desmopressin Acetate | BluePoint Laboratories | ANDA | Current |
| 68001-234 | Desmopressin Acetate | Desmopressin Acetate | BluePoint Laboratories | ANDA | Current |
| 68084-604 | Desmopressin Acetate | Desmopressin Acetate | American Health Packaging | ANDA | Current |
| 68084-604 | Desmopressin Acetate | Desmopressin Acetate | American Health Packaging | ANDA | Current |
| 68084-604 | Desmopressin Acetate | Desmopressin Acetate | American Health Packaging | ANDA | Current |
| 68084-604 | Desmopressin Acetate | Desmopressin Acetate | American Health Packaging | ANDA | Current |
| 68084-604 | Desmopressin Acetate | Desmopressin Acetate | American Health Packaging | ANDA | Current |
| 68084-606 | Desmopressin Acetate | Desmopressin Acetate | American Health Packaging | ANDA | Current |
| 68084-606 | Desmopressin Acetate | Desmopressin Acetate | American Health Packaging | ANDA | Current |
| 68084-606 | Desmopressin Acetate | Desmopressin Acetate | American Health Packaging | ANDA | Current |
| 68084-606 | Desmopressin Acetate | Desmopressin Acetate | American Health Packaging | ANDA | Current |
| 68084-606 | Desmopressin Acetate | Desmopressin Acetate | American Health Packaging | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8916 | ORIG | 2005-07-08 |