This site is intended for healthcare professionals
FDA Hero Banner - Multi-coloured pills and tablets
  • Home
  • /
  • Drugs
  • /
  • E
  • /
  • Erlotinib
  • /
  • Erlotinib ERLOTINIB HYDROCHLORIDE 100 mg/1 Cadila Healthcare Limited
FDA Drug information

Erlotinib

Read time: 1 mins
Marketing start date: 04 May 2024
...
 

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

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.