Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021574
Company: ANDRX LABS LLC
Company: ANDRX LABS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FORTAMET | METFORMIN HYDROCHLORIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
FORTAMET | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | 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 |
---|---|---|---|---|---|---|---|
04/27/2004 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21574_fortamet_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21574ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021574s000_ForametTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/05/2017 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021574s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021574Orig1s020ltr.pdf | |
05/18/2015 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/08/2018 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021574s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021574Orig1s017ltr.pdf | |
07/29/2008 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021574s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021574s010ltr.pdf | |
04/19/2007 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021574s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021574s006)_LTR.pdf | |
02/08/2006 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021574s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/08/2018 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021574s017lbl.pdf | |
04/05/2017 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021574s020lbl.pdf | |
07/29/2008 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021574s010lbl.pdf | |
04/19/2007 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021574s006lbl.pdf | |
04/27/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21574_fortamet_lbl.pdf |
FORTAMET
TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FORTAMET | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 021574 | ANDRX LABS LLC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 213651 | AJANTA PHARMA LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 090692 | LUPIN LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 200690 | MYLAN PHARMS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 203832 | NOSTRUM LABS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 209674 | NOVAST LABS |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 209993 | QINGDAO BAHEAL PHARM |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 214629 | SCIEGEN PHARMS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 213247 | TWI PHARMS |