← FDA Drug Approvals (Drugs@FDA)
LORATADINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2006-02-14
Drug application
- FDA Application #
ANDA076471- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LORATADINE
- Generic name
- LORATADINE
- Active ingredients
- LORATADINE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- APOTEX
- Manufacturer
- Selder, S.A. de C.V.
- First approval
- 2006-02-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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