Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021748
Company: SANTARUS INC
Company: SANTARUS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLUMETZA | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB3 | Yes | No |
GLUMETZA | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB3 | Yes | 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 |
---|---|---|---|---|---|---|---|
06/03/2005 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021748lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021748ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021748s000_GlumetzaTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/07/2018 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021748s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021748Orig1s025ltr.pdf | |
04/05/2017 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021748s020lbl.pdf | |
10/27/2015 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/13/2011 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021748s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021748s010ltr.pdf | |
02/25/2010 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021748s008ltr.pdf |
06/16/2009 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021748s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021748s005ltr.pdf | |
12/28/2007 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/01/2006 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021748s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021748s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/07/2018 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021748s025lbl.pdf | |
11/07/2018 | SUPPL-25 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021748s025lbl.pdf | |
04/05/2017 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021748s020lbl.pdf | |
04/13/2011 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021748s010lbl.pdf | |
06/16/2009 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021748s005lbl.pdf | |
11/01/2006 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021748s002lbl.pdf | |
06/03/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021748lbl.pdf |
GLUMETZA
TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLUMETZA | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 021748 | SANTARUS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 203755 | ACTAVIS LABS FL INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 213962 | AJANTA PHARMA LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 213356 | APOTEX |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 212969 | GLENMARK PHARMS LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 213344 | GRANULES |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 091664 | LUPIN LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 212448 | MICRO LABS |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 212681 | PRINSTON INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 215629 | RK PHARMA |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 213334 | SCIEGEN PHARMS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 202917 | SUN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLUMETZA | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 021748 | SANTARUS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 203755 | ACTAVIS LABS FL INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 213962 | AJANTA PHARMA LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 213356 | APOTEX |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 212969 | GLENMARK PHARMS LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 213344 | GRANULES |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 091664 | LUPIN LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 211163 | MACLEODS PHARMS LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 212448 | MICRO LABS |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 212681 | PRINSTON INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 215629 | RK PHARMA |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 213334 | SCIEGEN PHARMS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 202917 | SUN PHARM |