Details for New Drug Application (NDA): 204957
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The generic ingredient in ACETAMINOPHEN is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
Summary for 204957
Tradename: | ACETAMINOPHEN |
Applicant: | B Braun Medical Inc |
Ingredient: | acetaminophen |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 204957
Suppliers and Packaging for NDA: 204957
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAMINOPHEN | acetaminophen | SOLUTION;INTRAVENOUS | 204957 | NDA | B. Braun Medical Inc. | 0264-4050 | 0264-4050-80 | 24 CONTAINER in 1 CASE (0264-4050-80) / 50 mL in 1 CONTAINER |
ACETAMINOPHEN | acetaminophen | SOLUTION;INTRAVENOUS | 204957 | NDA | B. Braun Medical Inc. | 0264-4050 | 0264-4050-90 | 24 CONTAINER in 1 CASE (0264-4050-90) / 50 mL in 1 CONTAINER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/50ML (10MG/ML) | ||||
Approval Date: | Feb 18, 2021 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) | ||||
Approval Date: | Feb 18, 2021 | TE: | RLD: | Yes |
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