Details for New Drug Application (NDA): 018315
NDA 018315 describes GLYCINE 1.5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Hospira, and Otsuka Icu Medcl, and is included in four NDAs. It is available from two suppliers. Additional details are available on the GLYCINE 1.5% IN PLASTIC CONTAINER profile page.
The generic ingredient in GLYCINE 1.5% IN PLASTIC CONTAINER is glycine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the glycine profile page.
The generic ingredient in GLYCINE 1.5% IN PLASTIC CONTAINER is glycine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the glycine profile page.
Summary for 018315
| Tradename: | GLYCINE 1.5% IN PLASTIC CONTAINER |
| Applicant: | Otsuka Icu Medcl |
| Ingredient: | glycine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 018315
Suppliers and Packaging for NDA: 018315
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYCINE 1.5% IN PLASTIC CONTAINER | glycine | SOLUTION;IRRIGATION | 018315 | NDA | ICU Medical Inc. | 0990-7974 | 0990-7974-08 | 4 POUCH in 1 CASE (0990-7974-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;IRRIGATION | Strength | 1.5GM/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No | ||||
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