Application 017060
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NOR-QD | NORETHINDRONE | TABLET;ORAL-28 | 0.35MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52544-629 | Nora BE | Norethindrone | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 52544-629 | Nora BE | Norethindrone | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 52544-629 | Nora BE | Norethindrone | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 52544-629 | Nora BE | Norethindrone | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 52544-629 | Nora BE | Norethindrone | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 538 | SUPPL | 2005-10-25 |