NDC 46708-565

ERLOTINIB HYDROCHLORIDE

Erlotinib Hydrochloride

ERLOTINIB HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Erlotinib Hydrochloride.

Product ID46708-565_ab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b
NDC46708-565
Product TypeHuman Prescription Drug
Proprietary NameERLOTINIB HYDROCHLORIDE
Generic NameErlotinib Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2021-07-09
Marketing CategoryANDA /
Application NumberANDA214719
Labeler NameAlembic Pharmaceuticals Limited
Substance NameERLOTINIB HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 46708-565-30

30 TABLET, FILM COATED in 1 BOTTLE (46708-565-30)
Marketing Start Date2021-07-09
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "ERLOTINIB HYDROCHLORIDE" or generic name "Erlotinib Hydrochloride"

NDCBrand NameGeneric Name
0378-7131Erlotinib Hydrochlorideerlotinib hydrochloride
0378-7132Erlotinib Hydrochlorideerlotinib hydrochloride
0378-7133Erlotinib Hydrochlorideerlotinib hydrochloride
42292-051Erlotinib Hydrochlorideerlotinib hydrochloride
42292-052Erlotinib Hydrochlorideerlotinib hydrochloride
42292-053Erlotinib Hydrochlorideerlotinib hydrochloride
46708-565ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
46708-566ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
46708-567ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
62332-565ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
62332-566ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
62332-567ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
69539-090Erlotinib HydrochlorideErlotinib Hydrochloride
69539-091Erlotinib HydrochlorideErlotinib Hydrochloride
69539-092Erlotinib HydrochlorideErlotinib Hydrochloride
72205-080Erlotinib HydrochlorideErlotinib Hydrochloride
72205-081Erlotinib HydrochlorideErlotinib Hydrochloride
72205-082Erlotinib HydrochlorideErlotinib Hydrochloride
51991-890ErlotinibErlotinib Hydrochloride
51991-891ErlotinibErlotinib Hydrochloride
51991-892ErlotinibErlotinib Hydrochloride
72485-217ErlotinibErlotinib hydrochloride
72485-218ErlotinibErlotinib hydrochloride
72485-219ErlotinibErlotinib hydrochloride
50242-062TARCEVAerlotinib hydrochloride
50242-063TARCEVAerlotinib hydrochloride
50242-064TARCEVAerlotinib hydrochloride
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