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Details for New Drug Application (NDA): 050754

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NDA 050754 describes AMOXIL, which is a drug marketed by Dr Reddys Labs Inc and Glaxosmithkline and is included in eight NDAs. It is available from five suppliers. Additional details are available on the AMOXIL profile page.

The generic ingredient in AMOXIL is amoxicillin. There are forty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.

Summary for NDA: 050754

Dr Reddys Labs Inc
Therapeutic Class:Antibacterials

Pharmacology for NDA: 050754


Suppliers and Packaging for NDA: 050754

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 050754 NDA Dr Reddys Laboratories Inc 43598-219 43598-219-01 100 TABLET, FILM COATED in 1 BOTTLE (43598-219-01)
TABLET;ORAL 050754 NDA Dr Reddys Laboratories Inc 43598-219 43598-219-14 20 TABLET, FILM COATED in 1 BOTTLE (43598-219-14)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength875MG
Approval Date:Jul 10, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 10, 1998TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.