Details for New Drug Application (NDA): 205323
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The generic ingredient in HEPARIN SODIUM is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 205323
Tradename: | HEPARIN SODIUM |
Applicant: | Gland |
Ingredient: | heparin sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205323
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 205323 | ANDA | Gland Pharma Limited | 68083-136 | 68083-136-25 | 25 VIAL in 1 CARTON (68083-136-25) / 1 mL in 1 VIAL (68083-136-01) |
HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 205323 | ANDA | Gland Pharma Limited | 68083-427 | 68083-427-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (68083-427-25) / 10 mL in 1 VIAL, MULTI-DOSE (68083-427-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5,000 UNITS/ML | ||||
Approval Date: | Feb 6, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1,000 UNITS/ML | ||||
Approval Date: | Nov 18, 2019 | TE: | AP | RLD: | No |
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