Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 076706
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 12/14/2004 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/01/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/01/2019 | SUPPL-14 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/30/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/11/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/07/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/29/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |
METFORMIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 021202 | BRISTOL MYERS SQUIBB |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076172 | ACTAVIS LABS FL INC |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209303 | ALIGNSCIENCE PHARMA |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206145 | ALKEM LABS LTD |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 078596 | AMNEAL PHARMS NY |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076706 | APOTEX |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 079118 | AUROBINDO PHARMA LTD |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 207427 | BEXIMCO PHARMS USA |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 077060 | CADILA |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 078321 | CSPC OUYI |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209313 | GRANULES INDIA LTD |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202306 | INTELLIPHARMACEUTICS |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 201991 | INVENTIA HLTHCARE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206955 | MACLEODS PHARMS LTD |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 090295 | MARKSANS PHARMA |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076756 | NOSTRUM PHARMS LLC |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 208880 | PRINSTON INC |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076873 | SANDOZ |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 077336 | SUN PHARM INDS (IN) |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076269 | TEVA |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 090014 | TORRENT |
TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021202 | BRISTOL MYERS SQUIBB |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076869 | ACTAVIS LABS FL INC |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206145 | ALKEM LABS LTD |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078596 | AMNEAL PHARMS NY |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076706 | APOTEX |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079118 | AUROBINDO PHARMA LTD |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076863 | BARR |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207427 | BEXIMCO PHARMS USA |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077078 | CADILA |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078321 | CSPC OUYI |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209313 | GRANULES INDIA LTD |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202306 | INTELLIPHARMACEUTICS |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206955 | MACLEODS PHARMS LTD |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090295 | MARKSANS PHARMA |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076756 | NOSTRUM PHARMS LLC |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208880 | PRINSTON INC |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077336 | SUN PHARM INDS (IN) |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076864 | TEVA |
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