Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062653
Company: WARNER CHILCOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DORYX DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE, DELAYED RELEASE;ORAL Discontinued 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
10/30/1985 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
03/26/2004 SUPPL-9 Labeling

Label is not available on this site.

11/10/2003 SUPPL-8 Labeling

Label is not available on this site.

05/11/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

03/23/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

02/06/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/31/1997 SUPPL-2 Manufacturing (CMC)

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