← FDA Drug Approvals (Drugs@FDA)
PRETOMANID
NDA · New Drug Application · Sponsor: MYLAN IRELAND LTD · Approved 2019-08-14
Drug application
- FDA Application #
NDA212862
- Application type
- New Drug Application
- Brand name
- PRETOMANID
- Generic name
- PRETOMANID
- Active ingredients
- PRETOMANID
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MYLAN IRELAND LTD
- Manufacturer
- Viatris Specialty LLC
- First approval
- 2019-08-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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