Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215570
Company: SYNTHON PHARMS INC
Company: SYNTHON PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PALBOCICLIB | PALBOCICLIB | 75MG | TABLET;ORAL | Prescription | AB | No | No |
PALBOCICLIB | PALBOCICLIB | 100MG | TABLET;ORAL | Prescription | AB | No | No |
PALBOCICLIB | PALBOCICLIB | 125MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/12/2024 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215570Orig1s000ltr.pdf |
PALBOCICLIB
TABLET;ORAL; 75MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PALBOCICLIB | PALBOCICLIB | 75MG | TABLET;ORAL | Prescription | No | AB | 215570 | SYNTHON PHARMS INC |
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PALBOCICLIB | PALBOCICLIB | 100MG | TABLET;ORAL | Prescription | No | AB | 215570 | SYNTHON PHARMS INC |
TABLET;ORAL; 125MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PALBOCICLIB | PALBOCICLIB | 125MG | TABLET;ORAL | Prescription | No | AB | 215570 | SYNTHON PHARMS INC |