CHILDREN’S ZYRTEC ALLERGY از شرکت J AND J CONSUMER INC

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

CHILDREN’S ZYRTEC ALLERGY از شرکت J AND J CONSUMER INC

New Drug Application (NDA): 021621

Company: J AND J CONSUMER INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN’S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued

None

Yes No
CHILDREN’S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued

None

Yes No
CHILDREN’S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE;ORAL Discontinued

None

Yes No
CHILDREN’S ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued

None

Yes No
CHILDREN’S ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued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
03/16/2004 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Letter (PDF)

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21621ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-621_Zyrtec.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2020 SUPPL-10

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021621Orig1s010lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021621Orig1s010ltr.pdf

11/16/2007 SUPPL-5 Efficacy-Rx To OTC Switch

Letter (PDF)

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021621s005ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019835s022_021621s005TOC.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2020 SUPPL-10

Manufacturing (CMC)

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021621Orig1s010lbl.pdf
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