0

CARNITOR از شرکت LEADIANT BIOSCI INC

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

CARNITOR از شرکت LEADIANT BIOSCI INC

New Drug Application (NDA): 020182

Company: LEADIANT BIOSCI INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARNITOR LEVOCARNITINE 200MG/ML INJECTABLE;INJECTION Prescription

AP

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
12/16/1992 ORIG-1 Approval

Type 3 – New Dosage Form

PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/17/2018 SUPPL-15 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020182s015lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/20182Orig1s015ltr.pdf

05/29/2015 SUPPL-13 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018948Orig1s026,019257Orig1s012,020182Orig1s013ltr.pdf

04/15/2002 SUPPL-8 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18948s22ltr.pdf

05/16/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/15/1999 SUPPL-6 Efficacy-New Indication

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182s6_Carnitor_prntlbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20182S6LTR.PDF

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182S6_Carnitor.cfm

12/15/1998 SUPPL-5 Labeling

Label is not available on this site.

12/01/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1997 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1995 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/07/1995 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/17/2018 SUPPL-15

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020182s015lbl.pdf
05/29/2015 SUPPL-13

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf
04/15/2002 SUPPL-8

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf
12/15/1999 SUPPL-6

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182s6_Carnitor_prntlbl.pdf

CARNITOR

INJECTABLE;INJECTION; 200MG/ML

TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARNITOR LEVOCARNITINE 200MG/ML INJECTABLE;INJECTION Prescription Yes AP 020182 LEADIANT BIOSCI INC
LEVOCARNITINE LEVOCARNITINE 200MG/ML INJECTABLE;INJECTION Prescription No AP 075861 AM REGENT
LEVOCARNITINE LEVOCARNITINE 200MG/ML INJECTABLE;INJECTION Prescription No AP 075567 HIKMA PHARMS
حتما بخوانید : CARMUSTINE از شرکت NAVINTA LLC
بخوانید  CONRAY از شرکت LIEBEL-FLARSHEIM
برچسب‌ها:

نظرات کاربران