Application 019959
- Type
- BLA
- Sponsor
- NOVO NORDISK INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 019959 | Novolin N | insulin isophane human | 351(a) | OTC | 2026-10-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NOVOLIN N | INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | INJECTABLE;INJECTION | 100 UNITS/ML | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 13 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0169-1834 | Novolin | Human Insulin | Novo Nordisk | NDA | Current |
| 0169-1834 | Novolin | Human Insulin | Novo Nordisk | NDA | Current |
| 0169-1834 | Novolin | Human Insulin | Novo Nordisk | BLA | Current |
| 0169-1834 | Novolin | Human Insulin | Novo Nordisk | BLA | Current |
| 0169-1834 | Novolin | Human Insulin | Novo Nordisk | NDA | Current |
| 0169-3004 | Novolin | Human Insulin | Novo Nordisk | NDA | Current |
| 0169-3004 | Novolin | Human Insulin | Novo Nordisk | BLA | Current |
| 0169-3004 | Novolin | Human Insulin | Novo Nordisk | BLA | Current |
| 0169-3004 | Novolin | Human Insulin | Novo Nordisk | NDA | Current |
| 50090-0498 | Novolin | Human Insulin | A-S Medication Solutions | BLA | Current |
| 50090-0498 | Novolin | Human Insulin | A-S Medication Solutions | BLA | Current |
| 50090-0498 | Novolin | Human Insulin | A-S Medication Solutions | NDA | Current |
| 64725-1834 | Novolin | Human Insulin | TYA Pharmaceuticals | NDA | Current |