Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208336
Company: SUNSHINE
Company: SUNSHINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | AB | No | No |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;850MG | TABLET;ORAL | Prescription | AB | No | No |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;1GM | TABLET;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 |
---|---|---|---|---|---|---|---|
08/30/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208336Orig1s000ltr.pdf |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
TABLET;ORAL; 2.5MG;500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
JENTADUETO | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | Yes | AB | 201281 | BOEHRINGER INGELHEIM |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | No | AB | 208336 | SUNSHINE |
TABLET;ORAL; 2.5MG;850MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
JENTADUETO | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;850MG | TABLET;ORAL | Prescription | Yes | AB | 201281 | BOEHRINGER INGELHEIM |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;850MG | TABLET;ORAL | Prescription | No | AB | 208336 | SUNSHINE |
TABLET;ORAL; 2.5MG;1GM
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
JENTADUETO | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;1GM | TABLET;ORAL | Prescription | Yes | AB | 201281 | BOEHRINGER INGELHEIM |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;1GM | TABLET;ORAL | Prescription | No | AB | 208336 | SUNSHINE |