Details for New Drug Application (NDA): 075618
✉ Email this page to a colleague
NDA 075618 describes BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, which is a drug marketed by Able, Hikma, Hikma Intl Pharms, Lgm Pharma, Nostrum Labs Inc, and Strides Pharma, and is included in six NDAs. It is available from five suppliers. Additional details are available on the BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE profile page.
The generic ingredient in BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE is acetaminophen; butalbital; caffeine; codeine phosphate. There are sixty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine; codeine phosphate profile page.
The generic ingredient in BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE is acetaminophen; butalbital; caffeine; codeine phosphate. There are sixty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine; codeine phosphate profile page.
Summary for 075618
| Tradename: | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE |
| Applicant: | Hikma Intl Pharms |
| Ingredient: | acetaminophen; butalbital; caffeine; codeine phosphate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 325MG;50MG;40MG;30MG | ||||
| Approval Date: | Mar 23, 2001 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
