Cyproheptadine Hydrochloride
Cyproheptadine Hydrochloride Oral Solution, USP 2 mg/ 5 mL
Approved
Approval ID
81d9523f-f945-4410-8b71-8b5fea48a3da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2022
Manufacturers
FDA
Patrin Pharma, Inc.
DUNS: 806841677
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 Code39328-544
Application NumberANDA209108
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyproheptadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (9)
CyproheptadineActive
Quantity: 2 mg in 5 mL
Code: 2YHB6175DO
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT