Cyclin-dependent kinase (CDK) inhibitors
Palbociclib
The FDA lists this product in 22 strengths and forms.
Composition
- Active ingredients
- PALBOCICLIB 125MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- PALBOCICLIB 100MG · CapsuleANDA212980-003 · Tentative approval
- PALBOCICLIB 125MG · CapsuleANDA212980-002 · Tentative approval
- PALBOCICLIB 125MG · CapsuleANDA213091-003 · Tentative approval
- PALBOCICLIB 75MG · CapsuleANDA213091-001 · Tentative approval
- PALBOCICLIB 100MG · CapsuleANDA213091-002 · Tentative approval
- PALBOCICLIB 100MG · TabletANDA215570-002 · Discontinued
- PALBOCICLIB 125MG · TabletThis page
- PALBOCICLIB 75MG · TabletANDA215570-001 · Discontinued
- PALBOCICLIB 100MG · CapsuleANDA213086-002 · Tentative approval
- PALBOCICLIB 125MG · CapsuleANDA213086-003 · Tentative approval
- PALBOCICLIB 100MG · CapsuleANDA213107-002 · Tentative approval
- PALBOCICLIB 125MG · CapsuleANDA213107-003 · Tentative approval
- PALBOCICLIB 75MG · CapsuleANDA213107-001 · Tentative approval
At a glance
- Brand name
- Palbociclib
- Drug class
- Cyclin-dependent kinase (CDK) inhibitors
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Zydus Lifesciences
- Status
- Discontinued
- FDA approval
- 5 Jun 2024
- Application
- ANDA215570-003
- RxCUI
- 1601374