Drugs@FDA: FDA-Approved Drugs
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | 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 |
---|---|---|---|---|---|---|---|
09/11/2013 | 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 |
---|---|---|---|---|---|
09/02/2022 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/29/2019 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/29/2019 | SUPPL-11 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
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11/29/2019 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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11/29/2019 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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11/29/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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11/29/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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11/29/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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11/05/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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03/19/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ZOLPIDEM TARTRATE
TABLET, EXTENDED RELEASE;ORAL; 6.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMBIEN CR | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021774 | SANOFI AVENTIS US |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200266 | APOTEX |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078970 | LUPIN LTD |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090107 | SANDOZ |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204170 | SUN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMBIEN CR | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021774 | SANOFI AVENTIS US |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200266 | APOTEX |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078970 | LUPIN LTD |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090107 | SANDOZ |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204170 | SUN PHARM |