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ACTICLATE CAP از شرکت ALMIRALL

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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

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208253s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208253Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208253Orig1s000TOC.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208253Orig1s000SumR.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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (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

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
حتما بخوانید : ACTHREL از شرکت FERRING
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