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
CROMOLYN SODIUM از شرکت SANDOZ INC
Abbreviated New Drug Application (ANDA): 075282
Company: SANDOZ INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CROMOLYN SODIUM | CROMOLYN SODIUM | 4% | SOLUTION/DROPS;OPHTHALMIC | Prescription |
AT |
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 |
|---|---|---|---|---|---|---|---|
| 06/16/1999 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75282ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/23/2002 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/01/2002 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/28/2002 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/07/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
CROMOLYN SODIUM
SOLUTION/DROPS;OPHTHALMIC; 4%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CROMOLYN SODIUM | CROMOLYN SODIUM | 4% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 074706 | AKORN |
| CROMOLYN SODIUM | CROMOLYN SODIUM | 4% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 075282 | SANDOZ INC |
منبع : www.accessdata.fda.gov
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