Details for New Drug Application (NDA): 017037
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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-two suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 017037
Tradename: | HEPARIN SODIUM |
Applicant: | Hikma |
Ingredient: | heparin sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 017037
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 017037 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-0391 | 0641-0391-12 | 25 VIAL in 1 PACKAGE (0641-0391-12) / 1 mL in 1 VIAL (0641-0391-37) |
HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 017037 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-0400 | 0641-0400-12 | 25 VIAL in 1 PACKAGE (0641-0400-12) / 1 mL in 1 VIAL (0641-0400-37) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1,000 UNITS/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5,000 UNITS/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10,000 UNITS/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
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