Application 017849
- Type
- NDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BRETHINE | TERBUTALINE SULFATE | TABLET;ORAL | 2.5MG | Yes | No |
| 002 | BRETHINE | TERBUTALINE SULFATE | TABLET;ORAL | 5MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62559-721 | Terbutaline Sulfate | Terbutaline Sulfate | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-721 | Terbutaline Sulfate | Terbutaline Sulfate | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-722 | Terbutaline Sulfate | Terbutaline Sulfate | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-722 | Terbutaline Sulfate | Terbutaline Sulfate | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 13922 | SUPPL | 2003-12-23 |