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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078970
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.

11/29/2019 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/29/2019 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert

Label is not available on this site.

11/29/2019 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/29/2019 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/29/2019 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/29/2019 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/29/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/05/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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 090153 ACTAVIS LABS FL INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078148 ANCHEN PHARMS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200266 APOTEX INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213592 BRECKENRIDGE
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 090153 ACTAVIS LABS FL INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078148 ANCHEN PHARMS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200266 APOTEX INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213592 BRECKENRIDGE
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
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