ALBENZA از شرکت IMPAX LABS INC

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داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ALBENZA از شرکت IMPAX LABS INC

New Drug Application (NDA): 020666

Company: IMPAX LABS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBENZA ALBENDAZOLE 200MG 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
06/11/1996 ORIG-1 Approval

Type 1 – New Molecular Entity

PRIORITY; Orphan

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020666Orig1s000rev.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/11/2019 SUPPL-12 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020666s012lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020666Orig1s012ltr.pdf

10/31/2018 SUPPL-11 Labeling-Package Insert, Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020666s011lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020666Orig1s011ltr.pdf

12/20/2017 SUPPL-10 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020666s010lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020666Orig1s010ltr.pdf

06/11/2015 SUPPL-9 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020666Orig1s009ltr.pdf

10/20/2009 SUPPL-6 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf

10/20/2009 SUPPL-5 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf

08/20/2007 SUPPL-4 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020666s004lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020666s004ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/11/2019 SUPPL-12

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020666s012lbl.pdf
10/31/2018 SUPPL-11

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020666s011lbl.pdf
10/31/2018 SUPPL-11

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020666s011lbl.pdf
12/20/2017 SUPPL-10

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020666s010lbl.pdf
06/11/2015 SUPPL-9

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf
10/20/2009 SUPPL-6

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf
10/20/2009 SUPPL-5

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf
08/20/2007 SUPPL-4

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020666s004lbl.pdf

ALBENZA

TABLET;ORAL; 200MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 208094 ACTAVIS ELIZABETH
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 210434 CIPLA LTD
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 211034 DR REDDYS
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 211117 EDENBRIDGE PHARMS
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 213435 MSN
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 210011 STRIDES PHARMA
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 208979 ZYDUS PHARMS
ALBENZA ALBENDAZOLE 200MG TABLET;ORAL Prescription Yes AB 020666 IMPAX LABS INC
حتما بخوانید : ALBENDAZOLE از شرکت DR REDDYS
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