Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203965
Company: WESTMINSTER PHARMS
Company: WESTMINSTER PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIGLITOL | MIGLITOL | 25MG | TABLET;ORAL | Prescription | AB | No | No |
MIGLITOL | MIGLITOL | 50MG | TABLET;ORAL | Prescription | AB | No | No |
MIGLITOL | MIGLITOL | 100MG | 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 |
---|---|---|---|---|---|---|---|
02/24/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203965Orig1s000ltr.pdf |
MIGLITOL
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYSET | MIGLITOL | 25MG | TABLET;ORAL | Prescription | Yes | AB | 020682 | PFIZER |
MIGLITOL | MIGLITOL | 25MG | TABLET;ORAL | Prescription | No | AB | 203965 | WESTMINSTER PHARMS |
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYSET | MIGLITOL | 50MG | TABLET;ORAL | Prescription | Yes | AB | 020682 | PFIZER |
MIGLITOL | MIGLITOL | 50MG | TABLET;ORAL | Prescription | No | AB | 203965 | WESTMINSTER PHARMS |
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYSET | MIGLITOL | 100MG | TABLET;ORAL | Prescription | Yes | AB | 020682 | PFIZER |
MIGLITOL | MIGLITOL | 100MG | TABLET;ORAL | Prescription | No | AB | 203965 | WESTMINSTER PHARMS |