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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217875
Company: ALKEM LABS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription AB No No
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription AB No No
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription AB No No
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;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
08/24/2023 ORIG-1 Approval STANDARD

Label is not available on this site.

TEMAZEPAM

CAPSULE;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RESTORIL TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription Yes AB 018163 SPECGX LLC
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 211542 ALEMBIC
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 217875 ALKEM LABS LTD
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 071457 NOVEL LABS INC
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 201781 PRINSTON INC
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 078581 SUN PHARM INDUSTRIES

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RESTORIL TEMAZEPAM 15MG CAPSULE;ORAL Prescription Yes AB 018163 SPECGX LLC
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 071620 ACTAVIS ELIZABETH
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 211542 ALEMBIC
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 217875 ALKEM LABS LTD
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 071427 CHARTWELL RX
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 071456 NOVEL LABS INC
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 201781 PRINSTON INC

CAPSULE;ORAL; 22.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RESTORIL TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription Yes AB 018163 SPECGX LLC
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 211542 ALEMBIC
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 217875 ALKEM LABS LTD
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 071457 NOVEL LABS INC
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 201781 PRINSTON INC

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RESTORIL TEMAZEPAM 30MG CAPSULE;ORAL Prescription Yes AB 018163 SPECGX LLC
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 071620 ACTAVIS ELIZABETH
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 211542 ALEMBIC
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 217875 ALKEM LABS LTD
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 071428 CHARTWELL RX
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 071457 NOVEL LABS INC
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 201781 PRINSTON INC
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