Relpax
RELPAX® (eletriptan hydrobromide) Tablets
Approved
Approval ID
6bb510c8-2ae2-4159-b4c6-0aec5e64b4c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
eletriptan hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-871
Application NumberNDA021016
Product Classification
M
Marketing Category
C73594
G
Generic Name
eletriptan hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2010
FDA Product Classification
INGREDIENTS (10)
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
eletriptan hydrobromideActive
Quantity: 40 mg in 1 1
Code: M41W832TA3
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT