Details for New Drug Application (NDA): 214039
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NDA 214039 describes ACETAMINOPHEN, ASPIRIN AND CAFFEINE, which is a drug marketed by Aurobindo Pharma Ltd, Granules, and Perrigo, and is included in three NDAs. It is available from forty suppliers. Additional details are available on the ACETAMINOPHEN, ASPIRIN AND CAFFEINE profile page.
The generic ingredient in ACETAMINOPHEN, ASPIRIN AND CAFFEINE is acetaminophen; aspirin; caffeine. There are sixty-six drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; aspirin; caffeine profile page.
The generic ingredient in ACETAMINOPHEN, ASPIRIN AND CAFFEINE is acetaminophen; aspirin; caffeine. There are sixty-six drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; aspirin; caffeine profile page.
Summary for 214039
| Tradename: | ACETAMINOPHEN, ASPIRIN AND CAFFEINE |
| Applicant: | Granules |
| Ingredient: | acetaminophen; aspirin; caffeine |
| Patents: | 0 |
Pharmacology for NDA: 214039
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 214039
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | acetaminophen; aspirin; caffeine | TABLET;ORAL | 214039 | ANDA | WALGREEN CO | 0363-9680 | 0363-9680-24 | 24 TABLET in 1 BOTTLE (0363-9680-24) |
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | acetaminophen; aspirin; caffeine | TABLET;ORAL | 214039 | ANDA | Safeway, Inc | 21130-681 | 21130-681-05 | 50 TABLET in 1 BOTTLE (21130-681-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 250MG;250MG;65MG | ||||
| Approval Date: | Feb 23, 2021 | TE: | RLD: | No | |||||
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