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
ALOMIDE از شرکت NOVARTIS
New Drug Application (NDA): 020191
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALOMIDE | LODOXAMIDE TROMETHAMINE | EQ 0.1% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/23/1993 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD; Orphan |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/26/2003 | SUPPL-18 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20191slr018_alomide_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20191slr018ltr.pdf |
||
| 12/04/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1999 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/31/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1997 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/17/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/26/2003 | SUPPL-18 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20191slr018_alomide_lbl.pdf |
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