← FDA Drug Approvals (Drugs@FDA)
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 1979-08-03
Drug application
- FDA Application #
ANDA086513- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
- Generic name
- SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
- Active ingredients
- HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MYLAN
- Manufacturer
- Mylan Pharmaceuticals Inc.
- First approval
- 1979-08-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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