Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205981
Company: MYLAN
Company: MYLAN
| 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 | No |
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/2023/205981Orig1s000ltr.pdf |
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 |
|---|---|---|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE; SAXAGLIPTIN 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 |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 500MG;EQ 5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206081 | SUN PHARM |
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 |
|---|---|---|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE; SAXAGLIPTIN 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 |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206081 | SUN PHARM |
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 |
|---|---|---|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE; SAXAGLIPTIN 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 |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206081 | SUN PHARM |