Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076177
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAMILA NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription AB1 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
10/21/2002 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
06/10/2011 SUPPL-6 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

CAMILA

TABLET;ORAL-28; 0.35MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAMILA NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 076177 MAYNE PHARMA
HEATHER NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 090454 GLENMARK GENERICS
INCASSIA NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 207304 AUROBINDO PHARMA LTD
NOR-QD NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription Yes AB1 017060 APIL
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 206807 ACCORD HLTHCARE
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 202260 AMNEAL PHARMS
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 091325 LUPIN LTD
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 201483 MYLAN LABS LTD
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 202014 NOVAST LABS

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