Details for New Drug Application (NDA): 216383
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NDA 216383 describes SILDENAFIL CITRATE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Granules, Hetero Labs Ltd V, Invagen Pharms, Lupin Ltd, MSN, Novitium Pharma, Somerset Theraps Llc, Taro, Teva Pharms Usa, Tris Pharma Inc, Zydus Lifesciences, Eugia Pharma, Actavis Grp Ptc, Amneal Pharms Ny, Apotex Corp, Appco, Cadila Pharms Ltd, Chartwell Rx, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Perrigo R And D, Reyoung, Rubicon, Sunshine, Teva, Teva Pharms, Torrent, Torrent Pharms Ltd, Umedica, and Watson Labs Inc, and is included in forty-seven NDAs. It is available from sixty-five suppliers. Additional details are available on the SILDENAFIL CITRATE profile page.
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.
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 216383
| Tradename: | SILDENAFIL CITRATE |
| Applicant: | Novitium Pharma |
| Ingredient: | sildenafil citrate |
| Patents: | 0 |
Pharmacology for NDA: 216383
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 216383
Suppliers and Packaging for NDA: 216383
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 216383 | ANDA | ANI Pharmaceuticals, Inc. | 70954-407 | 70954-407-10 | 30 TABLET in 1 BOTTLE (70954-407-10) |
| SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 216383 | ANDA | ANI Pharmaceuticals, Inc. | 70954-408 | 70954-408-10 | 30 TABLET in 1 BOTTLE (70954-408-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Aug 29, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Aug 29, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Aug 29, 2023 | TE: | AB | RLD: | No | ||||
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