Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205948
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYDEMY DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG TABLET;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
12/12/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

TYDEMY

TABLET;ORAL; 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription No AB 203594 WATSON LABS INC
SAFYRAL DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription Yes AB 022574 BAYER HLTHCARE
TYDEMY DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription No AB 205948 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