Details for New Drug Application (NDA): 091112
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NDA 091112 describes AMINO ACIDS, which is a drug marketed by B Braun and is included in one NDA. It is available from one supplier. Additional details are available on the AMINO ACIDS profile page.
The generic ingredient in AMINO ACIDS is amino acids. There are three hundred and fifty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amino acids profile page.
The generic ingredient in AMINO ACIDS is amino acids. There are three hundred and fifty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amino acids profile page.
Summary for 091112
| Tradename: | AMINO ACIDS |
| Applicant: | B Braun |
| Ingredient: | amino acids |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 091112
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMINO ACIDS | amino acids | INJECTABLE;INJECTION | 091112 | ANDA | B. Braun Medical Inc. | 0264-4500 | 0264-4500-00 | 8 CONTAINER in 1 CASE (0264-4500-00) / 1000 mL in 1 CONTAINER |
| AMINO ACIDS | amino acids | INJECTABLE;INJECTION | 091112 | ANDA | B. Braun Medical Inc. | 0264-4500 | 0264-4500-05 | 4 CONTAINER in 1 CASE (0264-4500-05) / 2000 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 15%(150GM/1000ML) | ||||
| Approval Date: | Apr 13, 2012 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 15%(300GM/2000ML) | ||||
| Approval Date: | Apr 13, 2012 | TE: | RLD: | No | |||||
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