Details for New Drug Application (NDA): 006460
✉ Email this page to a colleague
NDA 006460 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 006460
| Tradename: | PROTAMINE SULFATE |
| Applicant: | Lilly |
| Ingredient: | protamine sulfate |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/5ML (10MG/ML) | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 250MG/25ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
