Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091634
Company: GLENMARK GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALYACEN 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 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
01/19/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/16/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

03/29/2013 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

07/31/2012 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

ALYACEN 1/35

TABLET;ORAL-28; 0.035MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALYACEN 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 091634 GLENMARK GENERICS
CYCLAFEM 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 076337 VINTAGE PHARMS LLC
DASETTA 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 090948 NOVAST LABS LTD
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 206864 ACCORD HLTHCARE
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 070687 WATSON LABS TEVA
NORINYL 1+35 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 017565 ALLERGAN SALES LLC
NORTREL 1/35-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 072696 BARR
NYLIA 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 207056 AUROBINDO PHARMA LTD
ORTHO-NOVUM 1/35-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription Yes AB 017919 JANSSEN PHARMS
PIRMELLA 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 201512 LUPIN LTD

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