Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075025
Company: RISING PHARMA
Company: RISING PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
07/23/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75025_Lorazepam.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/27/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
08/30/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
04/28/2000 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
03/05/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/07/1999 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
LORAZEPAM
INJECTABLE;INJECTION; 2MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATIVAN | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018140 | HIKMA |
LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074243 | HOSPIRA |
LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074282 | HOSPIRA |
LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076150 | INTL MEDICATION SYS |
LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075025 | RISING PHARMA |