Details for New Drug Application (NDA): 215138
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NDA 215138 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 215138
| Tradename: | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE |
| Applicant: | Hikma |
| Ingredient: | acetaminophen; butalbital; caffeine; codeine phosphate |
| Patents: | 0 |
Pharmacology for NDA: 215138
| Mechanism of Action | Full Opioid Agonists |
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 215138
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 215138 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0650 | 0054-0650-25 | 100 CAPSULE in 1 BOTTLE (0054-0650-25) |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 215138 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3000 | 0054-3000-01 | 100 CAPSULE in 1 BOTTLE (0054-3000-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 325MG;50MG;40MG;30MG | ||||
| Approval Date: | Jan 26, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG;50MG;40MG;30MG | ||||
| Approval Date: | Jan 26, 2022 | TE: | AB | RLD: | No | ||||
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