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 از شرکت ALMIRALL
New Drug Application (NDA): 205931
Company: ALMIRALL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTICLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | No |
| ACTICLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/25/2014 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205931s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2020 | SUPPL-5 | 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-4 | 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-3 | 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 |
|
| 04/26/2016 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205931s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205931Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2020 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205931s005,208253s003lbl.pdf | |
| 12/26/2019 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205931s004, 208253s002lbl.pdf | |
| 11/15/2017 | SUPPL-3 |
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 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205931s002lbl.pdf | |
| 07/25/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205931s000lbl.pdf |
ACTICLATE
TABLET;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTICLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | Yes | AB | 205931 | ALMIRALL |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 211584 | AJANTA PHARMA LTD |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 211744 | ALEMBIC PHARMS LTD |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 209372 | AMNEAL PHARMS CO |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 209243 | APOTEX |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 214207 | EPIC PHARMA LLC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 208818 | LUPIN LTD |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 208765 | MAYNE PHARMA INC |
TABLET;ORAL; EQ 150MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTICLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | Yes | AB | 205931 | ALMIRALL |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 211584 | AJANTA PHARMA LTD |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 211744 | ALEMBIC PHARMS LTD |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 209372 | AMNEAL PHARMS CO |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 209243 | APOTEX |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 214207 | EPIC PHARMA LLC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 208818 | LUPIN LTD |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 208765 | MAYNE PHARMA INC |
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