Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090260
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORAZEPAM LORAZEPAM 2MG/ML CONCENTRATE;ORAL Prescription AA 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
06/15/2010 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
11/23/2010 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

LORAZEPAM

CONCENTRATE;ORAL; 2MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LORAZEPAM LORAZEPAM 2MG/ML CONCENTRATE;ORAL Prescription No AA 091383 AMNEAL PHARMS
LORAZEPAM LORAZEPAM 2MG/ML CONCENTRATE;ORAL Prescription No AA 200169 HI-TECH PHARMA CO
LORAZEPAM LORAZEPAM 2MG/ML CONCENTRATE;ORAL Prescription No AA 091407 LUPIN LTD
LORAZEPAM LORAZEPAM 2MG/ML CONCENTRATE;ORAL Prescription No AA 090260 PHARM ASSOC
LORAZEPAM LORAZEPAM 2MG/ML CONCENTRATE;ORAL Prescription No AA 079244 SAPTALIS PHARMS
LORAZEPAM INTENSOL LORAZEPAM 2MG/ML CONCENTRATE;ORAL Prescription No AA 072755 WEST-WARD PHARMS INT

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