CEPHALEXIN از شرکت SUN PHARM INDS LTD

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

CEPHALEXIN از شرکت SUN PHARM INDS LTD

Abbreviated New Drug Application (ANDA): 065007

Company: SUN PHARM INDS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Discontinued

None

No No
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;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
09/16/1999 ORIG-1 Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65007ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/02/2004 SUPPL-15 Labeling

Label is not available on this site.

11/03/2003 SUPPL-11 Labeling

Label is not available on this site.

11/03/2003 SUPPL-10 Labeling

Label is not available on this site.

09/05/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

09/05/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

06/29/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/18/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/18/2000 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/01/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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