Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090479
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Discontinued None No No
NORGESTIMATE; ETHINYL ESTRADIOL NORGESTIMATE; ETHINYL ESTRADIOL 0.215MG; 0.025MG TABLET; ORAL Prescription None No No
NORGESTIMATE; ETHINYL ESTRADIOL NORGESTIMATE; ETHINYL ESTRADIOL 0.25MG; 0.025MG 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
03/09/2011 ORIG-1 Approval

Label is not available on this site.

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