← FDA Drug Approvals (Drugs@FDA)
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ABHAI LLC · Approved 2017-02-21
Drug application
- FDA Application #
ANDA207487- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Generic name
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION
- Active ingredients
- HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ABHAI LLC
- Manufacturer
- KVK-Tech, Inc.
- First approval
- 2017-02-21
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown