Composition
- Active ingredients
- INDOMETHACIN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- INDOMETHACIN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SuppositoryThis page
- INDOMETHACIN 25MG/5ML · SuspensionNDA018332-001 · Prescription
- INDOMETHACIN 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CapsuleNDA016059-001 · Discontinued
- INDOMETHACIN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CapsuleNDA016059-002 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA017814.
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
- Indocin
- Active substance
- indomethacin
- Route
- Rectal
- Dosage form
- Suppository
- Applicant
- Zyla Life Sciences
- Status
- Discontinued
- FDA approval
- 13 Aug 1984
- Application
- NDA017814-001