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
ACTICLATE CAP از شرکت ALMIRALL
New Drug Application (NDA): 208253
Company: ALMIRALL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTICLATE CAP | DOXYCYCLINE HYCLATE | EQ 75MG BASE | CAPSULE;ORAL | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/2016 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208253s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2020 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205931s005,208253s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205931Orig1s005, 208253Orig1s003ltr.pdf |
||
| 12/26/2019 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205931s004, 208253s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205931Orig1s004, 208253Orig1s002ltr.pdf |
||
| 11/15/2017 | SUPPL-1 | Labeling-Package Insert, Labeling-Package Insert |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205931s003,208253s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205931Orig1s003,208253Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2020 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205931s005,208253s003lbl.pdf | |
| 12/26/2019 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205931s004, 208253s002lbl.pdf | |
| 11/15/2017 | SUPPL-1 |
Labeling-Package Insert |
Label (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205931s003,208253s001lbl.pdf |
| 11/15/2017 | SUPPL-1 |
Labeling-Package Insert |
Label (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205931s003,208253s001lbl.pdf |
| 04/26/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208253s000lbl.pdf |
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