Details for New Drug Application (NDA): 075794
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NDA 075794 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 075794
| Tradename: | ACETAMINOPHEN, ASPIRIN AND CAFFEINE |
| Applicant: | Perrigo |
| Ingredient: | acetaminophen; aspirin; caffeine |
| Patents: | 0 |
Pharmacology for NDA: 075794
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 075794
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | acetaminophen; aspirin; caffeine | TABLET;ORAL | 075794 | ANDA | L. Perrigo Company | 0113-0374 | 0113-0374-62 | 1 BOTTLE in 1 CARTON (0113-0374-62) / 24 TABLET, FILM COATED in 1 BOTTLE |
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | acetaminophen; aspirin; caffeine | TABLET;ORAL | 075794 | ANDA | L. Perrigo Company | 0113-0374 | 0113-0374-78 | 1 BOTTLE in 1 CARTON (0113-0374-78) / 100 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 250MG;250MG;65MG | ||||
| Approval Date: | Nov 26, 2001 | TE: | RLD: | No | |||||
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