Details for New Drug Application (NDA): 014134
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NDA 014134 describes PROTOPAM CHLORIDE, which is a drug marketed by Baxter Hlthcare Corp and Wyeth Ayerst and is included in two NDAs. It is available from one supplier. Additional details are available on the PROTOPAM CHLORIDE profile page.
The generic ingredient in PROTOPAM CHLORIDE is pralidoxime chloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pralidoxime chloride profile page.
The generic ingredient in PROTOPAM CHLORIDE is pralidoxime chloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pralidoxime chloride profile page.
Summary for 014134
| Tradename: | PROTOPAM CHLORIDE |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | pralidoxime chloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 014134
| Mechanism of Action | Cholinesterase Reactivators |
Suppliers and Packaging for NDA: 014134
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROTOPAM CHLORIDE | pralidoxime chloride | INJECTABLE;INJECTION | 014134 | NDA | Baxter Healthcare Corporation | 60977-141 | 60977-141-01 | 6 VIAL, SINGLE-DOSE in 1 PACKAGE (60977-141-01) / 20 mL in 1 VIAL, SINGLE-DOSE (60977-141-27) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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