Application 076887
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TERBUTALINE SULFATE | TERBUTALINE SULFATE | INJECTABLE;INJECTION | 1MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0404-9962 | Terbutaline Sulfate | Terbutaline Sulfate | Henry Schein, Inc. | ANDA | Current |
| 0404-9962 | Terbutaline Sulfate | Terbutaline Sulfate | Henry Schein, Inc. | ANDA | Current |
| 52584-665 | Terbutaline Sulfate | Terbutaline Sulfate | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-665 | Terbutaline Sulfate | Terbutaline Sulfate | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-665 | Terbutaline Sulfate | Terbutaline Sulfate | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-665 | Terbutaline Sulfate | Terbutaline Sulfate | General Injectables & Vaccines, Inc | ANDA | Current |
| 63323-665 | Terbutaline Sulfate | TERBUTALINE SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-665 | Terbutaline Sulfate | TERBUTALINE SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-665 | Terbutaline Sulfate | TERBUTALINE SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23840 | ORIG | 2011-02-17 |