Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075352
Company: NOVITIUM PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE 5MG CAPSULE;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
11/30/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75352ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2006 SUPPL-3 Labeling

Label is not available on this site.

SELEGILINE HYDROCHLORIDE

CAPSULE;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 CAPSULE;ORAL Prescription No AB 075321 APOTEX
SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 075352 NOVITIUM PHARMA
SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 206803 RISING

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