Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205980
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SAXAGLIPTIN | SAXAGLIPTIN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
SAXAGLIPTIN | SAXAGLIPTIN HYDROCHLORIDE | EQ 5MG BASE | TABLET;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 |
---|---|---|---|---|---|---|---|
07/31/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205980Orig1s000TA_ltr.pdf |
SAXAGLIPTIN
TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SAXAGLIPTIN | SAXAGLIPTIN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 205972 | AUROBINDO PHARMA |
SAXAGLIPTIN | SAXAGLIPTIN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 205994 | GLENMARK PHARMS LTD |
SAXAGLIPTIN | SAXAGLIPTIN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 205980 | MYLAN |
SAXAGLIPTIN | SAXAGLIPTIN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 206078 | SUN PHARM |
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SAXAGLIPTIN | SAXAGLIPTIN HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205972 | AUROBINDO PHARMA |
SAXAGLIPTIN | SAXAGLIPTIN HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205994 | GLENMARK PHARMS LTD |
SAXAGLIPTIN | SAXAGLIPTIN HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205980 | MYLAN |
SAXAGLIPTIN | SAXAGLIPTIN HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 206078 | SUN PHARM |