Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020682
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLYSET | MIGLITOL | 25MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
GLYSET | MIGLITOL | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
GLYSET | MIGLITOL | 100MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
12/18/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020682orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/14/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/17/2012 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020682s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020682Orig1s010ltr.pdf | |
04/24/2009 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020682s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020682s008ltr.pdf | |
09/29/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/23/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/06/1999 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/16/1999 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020682S001_Glyset_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020682S001_Glyset.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/17/2012 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020682s010lbl.pdf | |
04/24/2009 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020682s008lbl.pdf |
GLYSET
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 |