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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207678
Company: DR REDDYS LABS SA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 500MG;EQ 5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1GM;EQ 2.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1GM;EQ 5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/09/2023 ORIG-1 Approval STANDARD

Label is not available on this site.

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 500MG;EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 500MG;EQ 5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207678 DR REDDYS LABS SA
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 500MG;EQ 5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205981 MYLAN

TABLET, EXTENDED RELEASE;ORAL; 1GM;EQ 2.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1GM;EQ 2.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207678 DR REDDYS LABS SA
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1GM;EQ 2.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205981 MYLAN

TABLET, EXTENDED RELEASE;ORAL; 1GM;EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1GM;EQ 5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207678 DR REDDYS LABS SA
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1GM;EQ 5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205981 MYLAN
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