Details for New Drug Application (NDA): 209942
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NDA 209942 describes ALYQ, which is a drug marketed by Teva Pharms Inc and Teva Pharms Usa and is included in two NDAs. It is available from three suppliers. Additional details are available on the ALYQ profile page.
The generic ingredient in ALYQ is tadalafil. There are twenty-five drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
The generic ingredient in ALYQ is tadalafil. There are twenty-five drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 209942
| Tradename: | ALYQ |
| Applicant: | Teva Pharms Usa |
| Ingredient: | tadalafil |
| Patents: | 0 |
Pharmacology for NDA: 209942
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 209942
Suppliers and Packaging for NDA: 209942
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALYQ | tadalafil | TABLET;ORAL | 209942 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3334 | 0093-3334-06 | 60 TABLET, FILM COATED in 1 BOTTLE (0093-3334-06) |
| ALYQ | tadalafil | TABLET;ORAL | 209942 | ANDA | AvKARE | 42291-804 | 42291-804-60 | 60 TABLET, FILM COATED in 1 BOTTLE (42291-804-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Feb 5, 2019 | TE: | AB2 | RLD: | No | ||||
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