Composition
- Active ingredients
- DROSPIRENONE 4MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DROSPIRENONE 3.5MG · Tablet, chewableNDA216285-001 · Discontinued
- DROSPIRENONE 4MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA216936.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Drospirenone
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Lupin LTD
- Status
- Tentative approval
- FDA approval
- 29 Oct 2024
- Application
- ANDA216936-001