Details for New Drug Application (NDA): 089454
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NDA 089454 describes PROTAMINE SULFATE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Lilly, and Pharmacia And Upjohn, and is included in five NDAs. It is available from two suppliers. Additional details are available on the PROTAMINE SULFATE profile page.
The generic ingredient in PROTAMINE SULFATE is protamine sulfate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the protamine sulfate profile page.
The generic ingredient in PROTAMINE SULFATE is protamine sulfate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the protamine sulfate profile page.
Summary for 089454
| Tradename: | PROTAMINE SULFATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | protamine sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 089454
| Mechanism of Action | Heparin Binding Activity |
| Physiological Effect | Reversed Anticoagulation Activity |
Suppliers and Packaging for NDA: 089454
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROTAMINE SULFATE | protamine sulfate | INJECTABLE;INJECTION | 089454 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1414 | 51662-1414-1 | 5 mL in 1 VIAL, SINGLE-DOSE (51662-1414-1) |
| PROTAMINE SULFATE | protamine sulfate | INJECTABLE;INJECTION | 089454 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1414 | 51662-1414-3 | 25 POUCH in 1 CASE (51662-1414-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1414-2) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Apr 7, 1987 | TE: | RLD: | No | |||||
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