FDA
Prometh Hydrochloride,Phenylephrine Hydrochloride W/Codeine Phosphate
Composition
- Active ingredients
- CODEINE PHOSPHATE 10MG/5ML; PHENYLEPHRINE HYDROCHLORIDE 5MG/5ML; PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA040660.
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
- Prometh Hydrochloride,Phenylephrine Hydrochloride W/Codeine Phosphate
- Active substance
- codeine phosphate
- Route
- Oral
- Dosage form
- Syrup
- Applicant
- Pai Holdings
- Status
- Prescription
- FDA approval
- 7 Dec 2006
- Application
- ANDA040660-001