CYSTARAN - 54482-020-01 - (cysteamine hydrochloride)

Alphabetical Index


Drug Information of CYSTARAN

Product NDC: 54482-020
Proprietary Name: CYSTARAN
Non Proprietary Name: cysteamine hydrochloride
Active Ingredient(s): 6.5    mg/mL & nbsp;   cysteamine hydrochloride
Administration Route(s): OPHTHALMIC
Dosage Form(s): SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of CYSTARAN

Product NDC: 54482-020
Labeler Name: Sigma-Tau Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA200740
Marketing Category: NDA
Start Marketing Date: 20121230

Package Information of CYSTARAN

Package NDC: 54482-020-01
Package Description: 15 mL in 1 BOTTLE (54482-020-01)

NDC Information of CYSTARAN

NDC Code 54482-020-01
Proprietary Name CYSTARAN
Package Description 15 mL in 1 BOTTLE (54482-020-01)
Product NDC 54482-020
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name cysteamine hydrochloride
Dosage Form Name SOLUTION
Route Name OPHTHALMIC
Start Marketing Date 20121230
Marketing Category Name NDA
Labeler Name Sigma-Tau Pharmaceuticals, Inc.
Substance Name CYSTEAMINE HYDROCHLORIDE
Strength Number 6.5
Strength Unit mg/mL
Pharmaceutical Classes Cysteine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA]

Complete Information of CYSTARAN


General Information