Details for New Drug Application (NDA): 213115
✉ Email this page to a colleague
NDA 213115 describes BUTALBITAL AND ACETAMINOPHEN, which is a drug marketed by Dr Reddys Labs Sa, Granules, Alvogen, Halsey, Larken Labs Inc, Lgm Pharma, Mikart, Ne Rx Pharma, Quagen, Senores Pharms, and Watson Labs, and is included in thirteen NDAs. It is available from nine suppliers. Additional details are available on the BUTALBITAL AND ACETAMINOPHEN profile page.
The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
Summary for 213115
| Tradename: | BUTALBITAL AND ACETAMINOPHEN |
| Applicant: | Granules |
| Ingredient: | acetaminophen; butalbital |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213115
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | CAPSULE;ORAL | 213115 | ANDA | Granules Pharmaceuticals Inc. | 70010-054 | 70010-054-01 | 100 CAPSULE in 1 BOTTLE (70010-054-01) |
| BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | CAPSULE;ORAL | 213115 | ANDA | Granules Pharmaceuticals Inc. | 70010-054 | 70010-054-05 | 500 CAPSULE in 1 BOTTLE (70010-054-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG;50MG | ||||
| Approval Date: | Nov 22, 2019 | TE: | AA | RLD: | No | ||||
Complete Access Available with Subscription
