Prozac
Prozac (Fluoxetine hydrochloride) capsule
Approved
Approval ID
4b8fcce1-abfc-4631-9975-9d66e178dab6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2009
Manufacturers
FDA
Stat Rx USA
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-843
Application NumberNDA018936
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2009
FDA Product Classification
INGREDIENTS (1)
Fluoxetine hydrochlorideActive
Quantity: 20 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIB