Details for New Drug Application (NDA): 213116
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NDA 213116 describes TROMETHAMINE, which is a drug marketed by B Braun Medical Inc and Milla Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the TROMETHAMINE profile page.
The generic ingredient in TROMETHAMINE is tromethamine. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tromethamine profile page.
The generic ingredient in TROMETHAMINE is tromethamine. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tromethamine profile page.
Summary for 213116
| Tradename: | TROMETHAMINE |
| Applicant: | Milla Pharms |
| Ingredient: | tromethamine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 213116
Suppliers and Packaging for NDA: 213116
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TROMETHAMINE | tromethamine | SOLUTION;INJECTION | 213116 | ANDA | MILLA PHARMACEUTICALS INC. | 71357-001 | 71357-001-01 | 6 BOTTLE, GLASS in 1 CASE (71357-001-01) / 500 mL in 1 BOTTLE, GLASS (71357-001-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 18GM/500ML (3.6GM/100ML) | ||||
| Approval Date: | Dec 31, 2024 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jul 1, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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