Registrants (1)
Ajanta Pharma Limited, Paithan
918594859
Manufacturing Establishments (1)
Ajanta Pharma Ltd., Dahej
Ajanta Pharma USA Inc.
Ajanta Pharma Limited, Paithan
862199968
Products (1)
Sildenafil
27241-175
ANDA212883
ANDA (C73584)
ORAL
December 18, 2023
SildenafilActive
Code: BW9B0ZE037Class: ACTIMQuantity: 10 mg in 1 mL
SORBITOLInactive
Code: 506T60A25RClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT