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SAPROPTERIN DIHYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZENARA · Approved 2025-06-11
Drug application
- FDA Application #
ANDA218797- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SAPROPTERIN DIHYDROCHLORIDE
- Generic name
- SAPROPTERIN DIHYDROCHLORIDE
- Active ingredients
- SAPROPTERIN DIHYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ZENARA
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- First approval
- 2025-06-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown