# SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
> **ANDA086513** · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 1979-08-03
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=086513)
---
*AI Analytics · CC0 1.0*