Details for New Drug Application (NDA): 210969
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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 210969
Tradename: | ACETAMINOPHEN |
Applicant: | Eugia Pharma |
Ingredient: | acetaminophen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 210969
Suppliers and Packaging for NDA: 210969
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAMINOPHEN | acetaminophen | SOLUTION;INTRAVENOUS | 210969 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1540 | 51662-1540-3 | 24 POUCH in 1 CASE (51662-1540-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1540-2) / 100 mL in 1 VIAL, SINGLE-DOSE |
ACETAMINOPHEN | acetaminophen | SOLUTION;INTRAVENOUS | 210969 | ANDA | Eugia US LLC | 55150-307 | 55150-307-24 | 24 VIAL, SINGLE-DOSE in 1 CARTON (55150-307-24) / 100 mL in 1 VIAL, SINGLE-DOSE (55150-307-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) | ||||
Approval Date: | Oct 21, 2020 | TE: | AP | RLD: | No |
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