Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203572
Company: AUROLIFE PHARMA LLC
Company: AUROLIFE PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | AB | No | No |
LORAZEPAM | LORAZEPAM | 2MG | TABLET;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 |
---|---|---|---|---|---|---|---|
12/22/2017 | 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 |
---|---|---|---|---|---|
09/27/2023 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/27/2023 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
LORAZEPAM
TABLET;ORAL; 0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATIVAN | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 017794 | BAUSCH |
LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 203572 | AUROLIFE PHARMA LLC |
LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078203 | LEADING |
LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077754 | OXFORD PHARMS |
LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 071141 | SANDOZ |
LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 076045 | SUN PHARM INDS LTD |
LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 072926 | WATSON LABS |
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATIVAN | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | Yes | AB | 017794 | BAUSCH |
LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 203572 | AUROLIFE PHARMA LLC |
LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 078203 | LEADING |
LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 077754 | OXFORD PHARMS |
LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 071141 | SANDOZ |
LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 071404 | SANDOZ |
LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 076045 | SUN PHARM INDS LTD |
LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 072927 | WATSON LABS |
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATIVAN | LORAZEPAM | 2MG | TABLET;ORAL | Prescription | Yes | AB | 017794 | BAUSCH |
LORAZEPAM | LORAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 203572 | AUROLIFE PHARMA LLC |
LORAZEPAM | LORAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 078203 | LEADING |
LORAZEPAM | LORAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 077754 | OXFORD PHARMS |
LORAZEPAM | LORAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 071141 | SANDOZ |
LORAZEPAM | LORAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 076045 | SUN PHARM INDS LTD |
LORAZEPAM | LORAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 072928 | WATSON LABS |