Application 040541
- Type
- ANDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SOTRADECOL | SODIUM TETRADECYL SULFATE | INJECTABLE;INJECTION | 20MG/2ML (10MG/ML) | No | Yes |
| 002 | SOTRADECOL | SODIUM TETRADECYL SULFATE | INJECTABLE;INJECTION | 60MG/2ML (30MG/ML) | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-4525 | Sotradecol | tetradecyl hydrogen sulfate (ester) | A-S Medication Solutions | ANDA | Current |
| 50090-4529 | Sotradecol | tetradecyl hydrogen sulfate (ester) | A-S Medication Solutions | ANDA | Current |
| 51662-1562 | SODIUM TETRADECYL SULFATE | SODIUM TETRADECYL SULFATE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1563 | (SOTRADECOL) SODIUM TETRADECYL SULFATE | (SOTRADECOL) SODIUM TETRADECYL SULFATE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 67457-162 | Sotradecol | tetradecyl hydrogen sulfate (ester) | Mylan Institutional LLC | ANDA | Current |
| 67457-162 | Sotradecol | tetradecyl hydrogen sulfate (ester) | Mylan Institutional LLC | ANDA | Current |
| 67457-162 | Sotradecol | tetradecyl hydrogen sulfate (ester) | Mylan Institutional LLC | ANDA | Current |
| 67457-163 | Sotradecol | tetradecyl hydrogen sulfate (ester) | Mylan Institutional LLC | ANDA | Current |
| 67457-163 | Sotradecol | tetradecyl hydrogen sulfate (ester) | Mylan Institutional LLC | ANDA | Current |
| 67457-163 | Sotradecol | tetradecyl hydrogen sulfate (ester) | Mylan Institutional LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 7670 | ORIG | 2004-11-16 |