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
CROLOM از شرکت BAUSCH AND LOMB
Abbreviated New Drug Application (ANDA): 074443
Company: BAUSCH AND LOMB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CROLOM | CROMOLYN SODIUM | 4% | SOLUTION/DROPS;OPHTHALMIC | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 01/30/1995 | 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 |
|---|---|---|---|---|---|
| 12/09/2002 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/27/2001 | SUPPL-19 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/07/2002 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/30/2001 | SUPPL-16 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/07/2001 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/27/2000 | SUPPL-14 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/27/1999 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/18/2000 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/01/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1999 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/16/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/26/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1998 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/23/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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