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CYPROHEPTADINE HYDROCHLORIDE

Cyproheptadine Hydrochloride Tablets USPRx only

Approved
Approval ID

355d65a6-0681-475f-beb7-42980ec5ece5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 21, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CYPROHEPTADINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53808-0950
Application NumberANDA040537
Product Classification
M
Marketing Category
C73584
G
Generic Name
CYPROHEPTADINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2010
FDA Product Classification

INGREDIENTS (5)

CYPROHEPTADINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: NJ82J0F8QC
Classification: ACTIR
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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CYPROHEPTADINE HYDROCHLORIDE - FDA Drug Approval Details