FdaApplication
ANDA 076528
Identifiers
- fda_app_no: ANDA076528
Properties
| Property | Value |
|---|---|
| applicant_name | ABLE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2003-08-21 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL |
| BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE | BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE | 40MG/30MG | Capsule;Oral |
2 products