Details for New Drug Application (NDA): 215570
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NDA 215570 describes PALBOCICLIB, which is a drug marketed by Synthon Pharms Inc and is included in one NDA. Additional details are available on the PALBOCICLIB profile page.
The generic ingredient in PALBOCICLIB is palbociclib. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.
The generic ingredient in PALBOCICLIB is palbociclib. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.
Summary for 215570
| Tradename: | PALBOCICLIB |
| Applicant: | Synthon Pharms Inc |
| Ingredient: | palbociclib |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | Jun 5, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 5, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
| Approval Date: | Jun 5, 2024 | TE: | AB | RLD: | No | ||||
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