اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CHOLAC از شرکت ALRA
Abbreviated New Drug Application (ANDA): 071331
Company: ALRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHOLAC | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/26/1988 | 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 |
|---|---|---|---|---|---|
| 11/03/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |
CHOLAC
SOLUTION;ORAL, RECTAL; 10GM/15ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHOLAC | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 071331 | ALRA |
| GENERLAC | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 074603 | WOCKHARDT BIO AG |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 074077 | AKORN |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 090502 | FRESENIUS KABI |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 203762 | TORRENT |
منبع : www.accessdata.fda.gov
نظرات کاربران