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
ALBUTEROL SULFATE از شرکت BAUSCH AND LOMB
Abbreviated New Drug Application (ANDA): 075358
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | 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 |
---|---|---|---|---|---|---|---|
03/29/2000 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-358_Albuterol%20Sulfate_prntlbl.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/21/2004 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
05/14/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
07/23/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
11/27/2001 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
09/21/2001 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/22/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
01/22/2001 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
01/22/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/29/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-358_Albuterol%20Sulfate_prntlbl.pdf |
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