Details of the Drug Formulations

General Information of Drug (ID: DM7RJXL)

• Drug Name: Imatinib Drug Info
• Synonyms: Cgp 57148; Glamox; Glamox (TN); Gleevec (TN); Glivec (TN); Imatinib (INN); Imatinib (STI571); Imatinib Methansulfonate; Imatinib [INN:BAN]; 112GI019; 152459-95-5; BKJ8M8G5HI; CCRIS 9076; CGP-57148; CHEMBL941; Imatinib free base; STI; UNII-BKJ8M8G5HI

Indication

Disease Entry	ICD 11	Status	REF
Acute lymphoblastic leukaemia	2A85	Approved	[1]
Blast phase chronic myelogenous leukemia, BCR-ABL1 positive		Approved	[2]
Choroidal neovascularization	9B76	Approved	[2]
Chronic eosinophilic leukemia		Approved	[2]
Chronic myelogenous leukaemia	2A20.0	Approved	[3]
Chronic myeloid leukaemia	2A20	Approved	[4]
Dermatofibrosarcoma protuberans		Approved	[2]
Gastrointestinal stromal tumour	2B5B	Approved	[2]
Leukemia		Approved	[2]
Malignant peripheral nerve sheath tumor		Approved	[2]
Myeloproliferative neoplasm	2A20	Approved	[2]
Pulmonary hypertension	BB01	Approved	[2]
Coronavirus Disease 2019 (COVID-19)	1D6Y	Phase 3	[5]
Intestinal cancer	2C0Z	Phase 3	[3]
Lung cancer	2C25.0	Phase 2	[3]
Idiopathic hypereosinophilic syndrome		Investigative	[2]
Middle East Respiratory Syndrome (MERS)	1D64	Investigative	[6]
Scleroderma	4A42	Investigative	[2]
Severe acute respiratory syndrome (SARS)	1D65	Investigative	[6]
Systemic mastocytosis	2A21.0	Investigative	[7]

• Therapeutic Class: Anticancer Agents
• Cross-matching ID:
  PubChem CID: 5291
  ChEBI ID: CHEBI:45783
  CAS Number: 152459-95-5
  TTD ID: D0AZ3C
  VARIDT ID: DR00032
  INTEDE ID: DR0858
  ACDINA ID: D00324

Full List of Drug Formulations Containing This Drug

Imatinib 100 mg tablet

Company	Formulation ID	FDA Description
Golden State Medical Supply	F10506	Lactose monohydrate; Sodium stearyl fumarate; Fd&c yellow no. 6; Magnesium stearate; Ferric oxide yellow; Talc; Titanium dioxide; Croscarmellose sodium; Silicon dioxide; Crospovidone (12 mpa.s at 5%); Hydroxypropyl cellulose (1200000 mw); Hypromellose 2910 (6 mpa.s); Microcrystalline cellulose
Teva Pharmaceuticals	F10507	Lactose monohydrate; Sodium stearyl fumarate; Fd&c yellow no. 6; Magnesium stearate; Ferric oxide yellow; Talc; Titanium dioxide; Croscarmellose sodium; Silicon dioxide; Crospovidone (12 mpa.s at 5%); Hydroxypropyl cellulose, unspecified; Hypromellose 2910 (6 mpa.s); Microcrystalline cellulose
NorthStar Rx; Sun Pharmaceutical Industries	F10501	Fd&c yellow no. 6; Magnesium stearate; Mannitol; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Crospovidone; Cellulose, microcrystalline; Copovidone k25-31; Hypromelloses; Polyethylene glycols
American Health Packaging	F10505	Fd&c yellow no. 6; Magnesium stearate; Mannitol; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Copovidone; Crospovidone (15 mpa.s at 5%); Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified
Novartis Pharmaceuticals Corporation	F10503	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Water; Crospovidone; Polyethylene glycol 4000; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses
Physicians Total Care	F10499	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Crospovidone; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols
Avera McKennan Hospital	F10509	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Crospovidone; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols
Apotex	F10504	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Crospovidone; Silicon dioxide; Hydroxypropyl cellulose (type l); Hypromellose 2910 (5 mpa.s); Polyethylene glycol 8000
Mylan Pharamceuticals	F10508	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Titanium dioxide; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Polyvinyl alcohol, unspecified
Mylan Pharamceuticals	F10510	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Titanium dioxide; Silicon dioxide; Crospovidone, unspecified; Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Polyvinyl alcohol, unspecified
AvPAK	F10502	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Hydroxypropyl cellulose (type l); Hypromellose 2910 (5 mpa.s); Polyethylene glycol 8000

Imatinib 400 mg tablet

Company	Formulation ID	FDA Description
Golden State Medical Supply	F10516	Lactose monohydrate; Sodium stearyl fumarate; Fd&c yellow no. 6; Magnesium stearate; Ferric oxide yellow; Talc; Titanium dioxide; Croscarmellose sodium; Silicon dioxide; Crospovidone (12 mpa.s at 5%); Hydroxypropyl cellulose (1200000 mw); Hypromellose 2910 (6 mpa.s); Microcrystalline cellulose
Teva Pharmaceuticals	F10517	Lactose monohydrate; Sodium stearyl fumarate; Fd&c yellow no. 6; Magnesium stearate; Ferric oxide yellow; Talc; Titanium dioxide; Croscarmellose sodium; Silicon dioxide; Crospovidone (12 mpa.s at 5%); Hydroxypropyl cellulose, unspecified; Hypromellose 2910 (6 mpa.s); Microcrystalline cellulose
NorthStar Rx; Sun Pharmaceutical Industries	F10511	Fd&c yellow no. 6; Magnesium stearate; Mannitol; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Crospovidone; Cellulose, microcrystalline; Copovidone k25-31; Hypromelloses; Polyethylene glycols
American Health Packaging	F10515	Fd&c yellow no. 6; Magnesium stearate; Mannitol; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Copovidone; Crospovidone (15 mpa.s at 5%); Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified
Novartis Pharmaceuticals Corporation	F10513	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Water; Crospovidone; Polyethylene glycol 4000; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses
Physicians Total Care	F10500	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Crospovidone; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols
Apotex; AvKARE	F10514	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Crospovidone; Silicon dioxide; Hydroxypropyl cellulose (type l); Hypromellose 2910 (5 mpa.s); Polyethylene glycol 8000
Mylan Pharamceuticals	F10518	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Titanium dioxide; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Polyvinyl alcohol, unspecified
Mylan Pharamceuticals	F10519	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Titanium dioxide; Silicon dioxide; Crospovidone, unspecified; Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Polyvinyl alcohol, unspecified
AvPAK	F10512	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Hydroxypropyl cellulose (type l); Hypromellose 2910 (5 mpa.s); Polyethylene glycol 8000

References

• [1] Drugs@FDA. U.S. Food and Drug Administration. U.S. Department of Health & Human Services. 2015
• [2] Imatinib FDA Label
• [3] URL: http://www.guidetopharmacology.org Nucleic Acids Res. 2015 Oct 12. pii: gkv1037. The IUPHAR/BPS Guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. (Ligand id: 5687).
• [4] FDA Approved Drug Products from FDA Official Website. 2019. Application Number: (ANDA) 078340.
• [5] ClinicalTrials.gov (NCT04356495) Treatments to Decrease the Risk of Hospitalization or Death in Elderly Outpatients With Symptomatic SARS-CoV-2 Infection (COVID-19). U.S. National Institutes of Health.
• [6] Coronaviruses - drug discovery and therapeutic options. Nat Rev Drug Discov. 2016 May;15(5):327-47.
• [7] Design and development of antisense drugs. Expert Opin. Drug Discov. 2008 3(10):1189-1207.