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Cyproheptadine Hydrochloride

Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution, USP)

Approved
Approval ID

949743a7-f922-4248-aa28-818236c80a67

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 11, 2011

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

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 Code68151-1728
Application NumberANDA040668
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyproheptadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2011
FDA Product Classification

INGREDIENTS (8)

CYPROHEPTADINE HYDROCHLORIDEActive
Quantity: 2 mg in 5 mL
Code: NJ82J0F8QC
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Cyproheptadine Hydrochloride - FDA Drug Approval Details