Drugs@FDA: FDA-Approved Drugs
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 | Discontinued | None | 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-Patient Package Insert, Labeling-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 |
---|---|---|---|---|---|---|---|---|
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 |
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 |
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 | 211052 | YICHANG HUMANWELL |
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