Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 072651
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;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
02/19/1992 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
01/19/2000 SUPPL-17 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/12/1998 SUPPL-16 Labeling

Label is not available on this site.

12/22/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/14/1996 SUPPL-14 Labeling

Label is not available on this site.

05/16/1996 SUPPL-13 Labeling

Label is not available on this site.

04/21/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/24/1994 SUPPL-11 Labeling

Label is not available on this site.

11/10/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/10/1993 SUPPL-9 Labeling

Label is not available on this site.

11/10/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/10/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/14/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/04/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/04/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/04/1993 SUPPL-3 Labeling

Label is not available on this site.

04/16/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/16/1992 SUPPL-1 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