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 TEVA PHARMS
Abbreviated New Drug Application (ANDA): 075271
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CROMOLYN SODIUM | CROMOLYN SODIUM | 10MG/ML | SOLUTION;INHALATION | Prescription |
AN |
No | 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 |
|---|---|---|---|---|---|---|---|
| 01/18/2000 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-271_Cromolyn%20Sodium_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/03/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/15/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/15/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/18/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-271_Cromolyn%20Sodium_prntlbl.pdf |
CROMOLYN SODIUM
SOLUTION;INHALATION; 10MG/ML
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CROMOLYN SODIUM | CROMOLYN SODIUM | 10MG/ML | SOLUTION;INHALATION | Prescription | No | AN | 209453 | AILEX PHARMS LLC |
| CROMOLYN SODIUM | CROMOLYN SODIUM | 10MG/ML | SOLUTION;INHALATION | Prescription | No | AN | 075271 | TEVA PHARMS |
| CROMOLYN SODIUM | CROMOLYN SODIUM | 10MG/ML | SOLUTION;INHALATION | Prescription | No | AN | 075346 | WOCKHARDT BIO AG |
منبع : www.accessdata.fda.gov
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