Details for New Drug Application (NDA): 212440
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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 212440
Tradename: | SILDENAFIL CITRATE |
Applicant: | Alkem Labs Ltd |
Ingredient: | sildenafil citrate |
Patents: | 0 |
Pharmacology for NDA: 212440
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 212440
Suppliers and Packaging for NDA: 212440
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SILDENAFIL CITRATE | sildenafil citrate | FOR SUSPENSION;ORAL | 212440 | ANDA | Ascend Laboratories, LLC | 67877-648 | 67877-648-11 | 1 BOTTLE, GLASS in 1 CARTON (67877-648-11) / 112 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 10MG BASE/ML | ||||
Approval Date: | Nov 27, 2019 | TE: | AB | RLD: | No |
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