eletriptan hydrobromide
These highlights do not include all the information needed to use ELETRIPTAN HYDROBROMIDE TABLETS safely and effectively. See full prescribing information for ELETRIPTAN HYDROBROMIDE TABLETS. ELETRIPTAN HYDROBROMIDE tablets, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
a65315d7-a30a-4c1f-95a9-30226e559c3d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2021
Manufacturers
FDA
Ajanta Pharma USA Inc.
DUNS: 557554156
Products 2
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 Code27241-040
Application NumberANDA205186
Product Classification
M
Marketing Category
C73584
G
Generic Name
eletriptan hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (9)
eletriptan hydrobromideActive
Quantity: 40 mg in 1 1
Code: M41W832TA3
Classification: ACTIM
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
fd&c yellow no. 6Inactive
Code: H77VEI93A8
Classification: IACT
eletriptan hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-039
Application NumberANDA205186
Product Classification
M
Marketing Category
C73584
G
Generic Name
eletriptan hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (9)
eletriptan hydrobromideActive
Quantity: 20 mg in 1 1
Code: M41W832TA3
Classification: ACTIM
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
fd&c yellow no. 6Inactive
Code: H77VEI93A8
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT