Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bionpharma Inc.
079637826
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
OrBion Pharmaceuticals Private Limited
Bionpharma Inc.
Bionpharma Inc.
854403569
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naratriptan
Product Details
NDC Product Code
69452-340Application Number
ANDA091441Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 19, 2023NaratriptanActive
Code: 10X8X4P12ZClass: ACTIMQuantity: 1 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Naratriptan
Product Details
NDC Product Code
69452-341Application Number
ANDA091441Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 19, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
NaratriptanActive
Code: 10X8X4P12ZClass: ACTIMQuantity: 2.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT