Details for New Drug Application (NDA): 089475
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NDA 089475 describes PROTAMINE SULFATE, which is a drug marketed by Pharmacia And Upjohn, Fresenius Kabi Usa, Hikma, and Lilly, 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 089475
| Tradename: | PROTAMINE SULFATE |
| Applicant: | Hikma |
| Ingredient: | protamine sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 250MG/25ML (10MG/ML) | ||||
| Approval Date: | Nov 5, 1986 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/5ML (10MG/ML) | ||||
| Approval Date: | Jun 7, 1988 | TE: | RLD: | No | |||||
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