FdaApplication
ANDA 203535
Identifiers
- fda_app_no: ANDA203535
Properties
| Property | Value |
|---|---|
| applicant_name | NOVEL LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2017-02-13 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML | SYRUP;ORAL |
1 product