Details for New Drug Application (NDA): 202023
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The generic ingredient in SILDENAFIL CITRATE is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 202023
Tradename: | SILDENAFIL CITRATE |
Applicant: | Amneal Pharms Ny |
Ingredient: | sildenafil citrate |
Patents: | 0 |
Pharmacology for NDA: 202023
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 202023
Suppliers and Packaging for NDA: 202023
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 202023 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1751 | 60219-1751-1 | 100 TABLET, FILM COATED in 1 BOTTLE (60219-1751-1) |
SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 202023 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1751 | 60219-1751-3 | 30 TABLET, FILM COATED in 1 BOTTLE (60219-1751-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Jun 27, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Jun 27, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Jun 27, 2018 | TE: | AB | RLD: | No |
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