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Generated: December 12, 2018

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Details for New Drug Application (NDA): 062226

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NDA 062226 describes LAROTID, which is a drug marketed by Dr Reddys Labs Inc and Glaxosmithkline and is included in two NDAs. It is available from one supplier. Additional details are available on the LAROTID profile page.

The generic ingredient in LAROTID is amoxicillin. There are forty-six drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.
Summary for 062226
Tradename:LAROTID
Applicant:Dr Reddys Labs Inc
Ingredient:amoxicillin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062226
Medical Subject Heading (MeSH) Categories for 062226
Suppliers and Packaging for NDA: 062226
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXIL amoxicillin FOR SUSPENSION;ORAL 062226 ANDA Dr Reddys Laboratories Inc 43598-209 43598-209-52 100 mL in 1 BOTTLE (43598-209-52)
AMOXIL amoxicillin FOR SUSPENSION;ORAL 062226 ANDA Dr Reddys Laboratories Inc 43598-209 43598-209-53 150 mL in 1 BOTTLE (43598-209-53)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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