Skip to content
Application 205323
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/ML | No | No |
| 002 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68083-136 | Heparin Sodium | Heparin Sodium | Gland Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 47136 | ORIG | 2017-02-08 |