Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074912
Company: BOSCOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB 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
04/30/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74912ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74912ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74912.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/22/2000 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/30/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74912ap_appltr_prntlbl_chemr.pdf

SELEGILINE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 074871 APOTEX INC
SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 074912 BOSCOGEN

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