Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 072285
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAPROTILINE HYDROCHLORIDE MAPROTILINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription None No Yes
MAPROTILINE HYDROCHLORIDE MAPROTILINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription None No No
MAPROTILINE HYDROCHLORIDE MAPROTILINE HYDROCHLORIDE 75MG TABLET;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
10/03/1988 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
07/17/2014 SUPPL-21 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/072285s021lbl.pdf
01/16/2008 SUPPL-17 Labeling

Label is not available on this site.

01/16/2008 SUPPL-16 Labeling

Label is not available on this site.

04/13/2006 SUPPL-14 Labeling

Label is not available on this site.

08/15/2005 SUPPL-13 Labeling

Label is not available on this site.

05/07/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/26/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/13/1998 SUPPL-9 Labeling

Label is not available on this site.

04/01/1996 SUPPL-8 Labeling

Label is not available on this site.

04/01/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/27/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/06/1993 SUPPL-5 Labeling

Label is not available on this site.

08/06/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/04/1992 SUPPL-2 Labeling

Label is not available on this site.

01/31/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/17/2014 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/072285s021lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English