Cystagon - 0378-9045-05 - (cysteamine bitartrate)

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Drug Information of Cystagon

Product NDC: 0378-9045
Proprietary Name: Cystagon
Non Proprietary Name: cysteamine bitartrate
Active Ingredient(s): 150    mg/1 & nbsp;   cysteamine bitartrate
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of Cystagon

Product NDC: 0378-9045
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020392
Marketing Category: NDA
Start Marketing Date: 19940815

Package Information of Cystagon

Package NDC: 0378-9045-05
Package Description: 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)

NDC Information of Cystagon

NDC Code 0378-9045-05
Proprietary Name Cystagon
Package Description 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)
Product NDC 0378-9045
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name cysteamine bitartrate
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 19940815
Marketing Category Name NDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name CYSTEAMINE BITARTRATE
Strength Number 150
Strength Unit mg/1
Pharmaceutical Classes Cysteine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA]

Complete Information of Cystagon


General Information