Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072755
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORAZEPAM INTENSOL LORAZEPAM 2MG/ML CONCENTRATE;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/28/1991 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
09/27/2017 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/29/2007 SUPPL-14 Labeling

Label is not available on this site.

09/14/2007 SUPPL-11 Labeling

Label is not available on this site.

04/20/2001 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/14/2001 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/08/1994 SUPPL-3 Labeling

Label is not available on this site.

LORAZEPAM INTENSOL

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 079244 PADDOCK LLC
LORAZEPAM LORAZEPAM 2MG/ML CONCENTRATE;ORAL Prescription No AA 090260 PHARM ASSOC
LORAZEPAM INTENSOL LORAZEPAM 2MG/ML CONCENTRATE;ORAL Prescription No AA 072755 WEST-WARD PHARMS INT

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