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FDA Approval

Sildenafil

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
July 20, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sildenafil(50 mg in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sildenafil

Product Details

NDC Product Code
0378-1659
Application Number
ANDA201171
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 20, 2018
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
Code: BW9B0ZE037Class: ACTIMQuantity: 50 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT

Sildenafil

Product Details

NDC Product Code
0378-1658
Application Number
ANDA201171
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 20, 2018
Code: BW9B0ZE037Class: ACTIMQuantity: 25 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Sildenafil

Product Details

NDC Product Code
0378-1660
Application Number
ANDA201171
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 20, 2018
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
Code: BW9B0ZE037Class: ACTIMQuantity: 100 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
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