← FDA Drug Approvals (Drugs@FDA)
NDA218193
NDA · New Drug Application · Sponsor: MYLAN PHARMS INC · Approved 2023-08-16
Drug application
- FDA Application #
NDA218193
- Application type
- New Drug Application
- Brand name
- —
- Generic name
- —
- Active ingredients
- —
- Dosage form
- —
- Route
- —
- Marketing status
- —
- Sponsor
- MYLAN PHARMS INC
- First approval
- 2023-08-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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