Details for New Drug Application (NDA): 214087
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NDA 214087 describes BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, which is a drug marketed by Aurolife Pharma Llc, Dr Reddys Labs Sa, Gilbert Labs, Graham Dm, Granules, Hikma, Key Therap, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Novast Labs, Nuvo Pharms Inc, Quagen, Senores Pharms, Taro, Mikart, Abhai Llc, Able, Actavis Labs Ut Inc, Alvogen, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in forty-five NDAs. It is available from thirty-seven suppliers. Additional details are available on the BUTALBITAL, ACETAMINOPHEN AND CAFFEINE profile page.
The generic ingredient in BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is acetaminophen; butalbital; caffeine. There are sixty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
The generic ingredient in BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is acetaminophen; butalbital; caffeine. There are sixty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 214087
| Tradename: | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| Applicant: | Senores Pharms |
| Ingredient: | acetaminophen; butalbital; caffeine |
| Patents: | 0 |
Pharmacology for NDA: 214087
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 214087
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | CAPSULE;ORAL | 214087 | ANDA | Seton Pharmaceuticals LLC | 13925-535 | 13925-535-01 | 100 CAPSULE in 1 BOTTLE (13925-535-01) |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | CAPSULE;ORAL | 214087 | ANDA | Seton Pharmaceuticals LLC | 13925-536 | 13925-536-01 | 100 CAPSULE in 1 BOTTLE (13925-536-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG;50MG;40MG | ||||
| Approval Date: | Aug 13, 2021 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 325MG;50MG;40MG | ||||
| Approval Date: | Aug 13, 2021 | TE: | AA | RLD: | No | ||||
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