Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077831
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CILOSTAZOL CILOSTAZOL 100MG 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
09/24/2012 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
03/29/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

CILOSTAZOL

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077030 APOTEX INC
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077708 BRECKENRIDGE PHARM
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077021 CASI PHARMS INC
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077831 CHARTWELL RX
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077208 SLATE
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077027 TEVA
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077024 WEST-WARD PHARMS INT

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