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 thirty-nine 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-three 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-three 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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