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  • Erlotinib ERLOTINIB HYDROCHLORIDE 100 mg/1 Cadila Healthcare Limited
FDA Drug information

Erlotinib

Read time: 1 mins
Marketing start date: 26 Nov 2024
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Summary of product characteristics


Effective Time

20200417

Version

1

Spl Product Data Elements

Erlotinib Erlotinib ERLOTINIB HYDROCHLORIDE ERLOTINIB CROSPOVIDONE (120 .MU.M) HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 POLYETHYLENE GLYCOL 4000 SILICON DIOXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE Off-white Round 913 Erlotinib Erlotinib ERLOTINIB HYDROCHLORIDE ERLOTINIB CROSPOVIDONE (120 .MU.M) HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 POLYETHYLENE GLYCOL 4000 SILICON DIOXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE Off-white Round 914 Erlotinib Erlotinib ERLOTINIB HYDROCHLORIDE ERLOTINIB CROSPOVIDONE (120 .MU.M) HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 POLYETHYLENE GLYCOL 4000 SILICON DIOXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE Off-white Round 915

Application Number

ANDA213065

Brand Name

Erlotinib

Generic Name

Erlotinib

Product Ndc

70771-1522

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Erlotinib Tablets, 25 mg 30 tablets NDC 70771-1521-3 Rx only Erlotinib Tablets, 100 mg 30 tablets NDC 70771-1522-3 Rx only Erlotinib Tablets, 150 mg 30 tablets NDC 70771-1523-3 Rx only 25 mg label 100 mg label 150 mg label

Drug section

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