Details for New Drug Application (NDA): 201171
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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 201171
Tradename: | SILDENAFIL CITRATE |
Applicant: | Mylan |
Ingredient: | sildenafil citrate |
Patents: | 0 |
Pharmacology for NDA: 201171
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 201171
Suppliers and Packaging for NDA: 201171
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 201171 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1658 | 0378-1658-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1658-01) |
SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 201171 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1658 | 0378-1658-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1658-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Mar 25, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Mar 25, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Mar 25, 2019 | TE: | AB | RLD: | No |
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