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BENZTROPINE MESYLATE از شرکت LANNETT CO 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

BENZTROPINE MESYLATE از شرکت LANNETT CO INC

Abbreviated New Drug Application (ANDA): 088877

Company: LANNETT CO INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued

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
04/11/1985 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/28/2002 SUPPL-25 Labeling

Label is not available on this site.

11/30/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/2000 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/27/1998 SUPPL-22 Labeling

Label is not available on this site.

07/02/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/02/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/27/1993 SUPPL-16 Labeling

Label is not available on this site.

08/28/1991 SUPPL-15 Labeling

Label is not available on this site.

05/27/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/12/1991 SUPPL-12 Labeling

Label is not available on this site.

12/29/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/29/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/29/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/29/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/29/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/19/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/19/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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