63020-534 : Iclusig 45 mg Oral Tablet, Film Coated

Labeler: Millenium Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Iclusig
Dosage Form: Oral Tablet, Film Coated
Application #: NDA203469
Rev. Date: 


Markings: AP4
Shapes:  Round
Colors:  White
Size (mm): 10
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 63020-534-30: 30 TABLET, FILM COATED IN 1 BOTTLE (63020‑534‑30)

Active Ingredients:

  • Ponatinib Hydrochloride

Dosage Strength:

  • 45 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Microcrystalline Cellulose
  • Sodium Starch Glycolate Type B Potato
  • Silicon Dioxide
  • Magnesium Stearate

Pharmaceutical Classes:

  • Kinase Inhibitor [EPC]
  • Protein Kinase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 63020-533 Iclusig 30 mg Oral Tablet, Film Coated by Millenium Pharmaceuticals Inc.
  • 63020-535 Iclusig 15 mg Oral Tablet, Film Coated by Millenium Pharmaceuticals Inc.
  • 76189-533 Iclusig 30 mg Oral Tablet, Film Coated by Ariad Pharmaceuticals, Inc.
  • 76189-534 Iclusig (As Ponatinib Hydrochloride) 45 mg Oral Tablet by Ariad Pharmaceuticals, Inc.
  • 76189-535 Iclusig (As Ponatinib Hydrochloride) 15 mg Oral Tablet by Ariad Pharmaceuticals, Inc.


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