MedPath
FDA Approval

SILDENAFIL

November 8, 2021

HUMAN PRESCRIPTION DRUG LABEL

Sildenafil(100 mg in 1 1)

Registrants (1)

Manufacturing Establishments (1)

Rubicon Research Private Limited

Advagen Pharma Ltd

Rubicon Research Private Limited

677604197

Products (3)

SILDENAFIL

72888-017

ANDA204882

ANDA (C73584)

ORAL

November 8, 2021

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: BW9B0ZE037Class: ACTIMQuantity: 100 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT

SILDENAFIL

72888-016

ANDA204882

ANDA (C73584)

ORAL

November 8, 2021

CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
Code: BW9B0ZE037Class: ACTIMQuantity: 50 mg in 1 1

SILDENAFIL

72888-015

ANDA204882

ANDA (C73584)

ORAL

November 8, 2021

CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
Code: BW9B0ZE037Class: ACTIMQuantity: 25 mg in 1 1
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