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
ALPROSTADIL از شرکت WEST-WARD PHARMS INT
Abbreviated New Drug Application (ANDA): 074815
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALPROSTADIL | ALPROSTADIL | 0.5MG/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 |
|---|---|---|---|---|---|---|---|
| 01/20/1998 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074815ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/11/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/2001 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
ALPROSTADIL
INJECTABLE;INJECTION; 0.5MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALPROSTADIL | ALPROSTADIL | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075196 | TEVA PHARMS USA |
| ALPROSTADIL | ALPROSTADIL | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074815 | WEST-WARD PHARMS INT |
| PROSTIN VR PEDIATRIC | ALPROSTADIL | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018484 | PFIZER |
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