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HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SANKALP LIFECARE · Approved 2019-06-11
Drug application
- FDA Application #
ANDA210663- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Generic name
- Homatropine Methylbromide
- Active ingredients
- HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- SANKALP LIFECARE
- First approval
- 2019-06-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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