Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201049
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE | 2MG;30MG | TABLET;ORAL | Prescription | AB | No | No |
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE | 4MG;30MG | TABLET;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 |
---|---|---|---|---|---|---|---|
01/04/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/24/2020 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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02/24/2020 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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07/23/2015 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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07/23/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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06/02/2015 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE
TABLET;ORAL; 2MG;30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DUETACT | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE | 2MG;30MG | TABLET;ORAL | Prescription | Yes | AB | 021925 | TAKEDA PHARMS USA |
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE | 2MG;30MG | TABLET;ORAL | Prescription | No | AB | 201049 | SANDOZ |
TABLET;ORAL; 4MG;30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DUETACT | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE | 4MG;30MG | TABLET;ORAL | Prescription | Yes | AB | 021925 | TAKEDA PHARMS USA |
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE | 4MG;30MG | TABLET;ORAL | Prescription | No | AB | 201049 | SANDOZ |