0

CLOBEX از شرکت GALDERMA LABS

تصویر پیدا نشد !

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

CLOBEX از شرکت GALDERMA LABS

New Drug Application (NDA): 021644

Company: GALDERMA LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBEX CLOBETASOL PROPIONATE 0.05% SHAMPOO;TOPICAL 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
02/05/2004 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21644_clobex_lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21644ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-644_Clobex.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2012 SUPPL-3 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535Orig1s003, 021644Orig1s003lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s003,021644Orig1s003ltr.pdf

08/17/2012 SUPPL-2 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021644s002lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021644Orig1s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2012 SUPPL-3

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535Orig1s003, 021644Orig1s003lbl.pdf
08/17/2012 SUPPL-2

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021644s002lbl.pdf
02/05/2004 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21644_clobex_lbl.pdf

CLOBEX

SHAMPOO;TOPICAL; 0.05%

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SHAMPOO;TOPICAL Prescription No AB 078854 ACTAVIS MID ATLANTIC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SHAMPOO;TOPICAL Prescription No AB 209871 AKORN
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SHAMPOO;TOPICAL Prescription No AB 213290 ALEOR DERMACEUTICALS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SHAMPOO;TOPICAL Prescription No AB 214895 AMNEAL
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SHAMPOO;TOPICAL Prescription No AB 090974 PERRIGO ISRAEL
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SHAMPOO;TOPICAL Prescription No AB 214867 TARO PHARMS
CLOBEX CLOBETASOL PROPIONATE 0.05% SHAMPOO;TOPICAL Prescription Yes AB 021644 GALDERMA LABS
بخوانید  BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE از شرکت MAYNE PHARMA INC
برچسب‌ها:

نظرات کاربران