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Application 019357
- Type
- NDA
- Sponsor
- QOL MEDCL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ETHAMOLIN | ETHANOLAMINE OLEATE | INJECTABLE;INJECTION | 50MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67871-479 | Ethamolin | Ethanolamine Oleate | QOL Medical, LLC. | NDA | Current |
| 67871-479 | Ethamolin | Ethanolamine Oleate | QOL Medical, LLC. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 1292 | SUPPL | 2002-02-05 |