0

CLOZAPINE از شرکت BARR LABS 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

CLOZAPINE از شرکت BARR LABS INC

Abbreviated New Drug Application (ANDA): 090308

Company: BARR LABS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription

AB

No No
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription

AB

No Yes
CLOZAPINE CLOZAPINE 12.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription

None

No 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
04/09/2018 ORIG-2 Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090308Orig1s000ltr.pdf

11/25/2015 ORIG-1 Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090308Orig1s000TAltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2021 SUPPL-9 REMS – MODIFIED – D-N-A

Label is not available on this site.

02/18/2021 SUPPL-8 REMS – MODIFIED – D-N-A

Label is not available on this site.

04/16/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

01/16/2019 SUPPL-3 REMS – MODIFIED – D-N-A

Label is not available on this site.

04/09/2021 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

CLOZAPINE

TABLET, ORALLY DISINTEGRATING;ORAL; 25MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN

TABLET, ORALLY DISINTEGRATING;ORAL; 100MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN
بخوانید  CARBIDOPA AND LEVODOPA از شرکت ANI PHARMS
برچسب‌ها:

نظرات کاربران