Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079244
Company: LANNETT CO INC
Company: LANNETT CO INC
| 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 |
|---|---|---|---|---|---|---|---|
| 04/28/2009 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/079244lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079244s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/06/2016 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/28/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/079244lbl.pdf |
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 | 079244 | LANNETT CO INC |
| 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 INTENSOL | LORAZEPAM | 2MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 072755 | HIKMA |
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