Details for New Drug Application (NDA): 208494
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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 208494
Tradename: | SILDENAFIL CITRATE |
Applicant: | Reyoung |
Ingredient: | sildenafil citrate |
Patents: | 0 |
Pharmacology for NDA: 208494
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 208494
Suppliers and Packaging for NDA: 208494
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 208494 | ANDA | AustarPharma LLC | 35561-251 | 35561-251-10 | 30 TABLET, FILM COATED in 1 BOTTLE (35561-251-10) |
SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 208494 | ANDA | AustarPharma LLC | 35561-251 | 35561-251-14 | 1000 TABLET, FILM COATED in 1 BOTTLE (35561-251-14) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Jun 12, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Jun 12, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Jun 12, 2020 | TE: | AB | RLD: | No |
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