Details for New Drug Application (NDA): 013025
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NDA 013025 describes THAM, which is a drug marketed by Hospira and is included in one NDA. It is available from one supplier. Additional details are available on the THAM profile page.
The generic ingredient in THAM is potassium chloride; sodium chloride; tromethamine. There are two hundred and forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the potassium chloride; sodium chloride; tromethamine profile page.
The generic ingredient in THAM is potassium chloride; sodium chloride; tromethamine. There are two hundred and forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the potassium chloride; sodium chloride; tromethamine profile page.
Summary for 013025
| Tradename: | THAM |
| Applicant: | Hospira |
| Ingredient: | tromethamine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 013025
Suppliers and Packaging for NDA: 013025
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THAM-E | potassium chloride; sodium chloride; tromethamine | INJECTABLE;INJECTION | 013025 | NDA | Hospira, Inc. | 0409-1593 | 0409-1593-04 | 6 BOTTLE, GLASS in 1 CASE (0409-1593-04) / 500 mL in 1 BOTTLE, GLASS (0409-1593-14) |
| THAM | tromethamine | SOLUTION;INJECTION | 013025 | NDA | Hospira, Inc. | 0409-1593 | 0409-1593-04 | 6 BOTTLE, GLASS in 1 CASE (0409-1593-04) / 500 mL in 1 BOTTLE, GLASS (0409-1593-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 370MG/VIAL;1.75GM/VIAL;36GM/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 18GM/500ML (3.6GM/100ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
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