Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073250
Company: LEADING PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;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
10/08/1991 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
05/21/2018 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

06/19/2001 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

12/31/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/12/1998 SUPPL-5 Labeling

Label is not available on this site.

01/24/1997 SUPPL-4 Labeling

Label is not available on this site.

07/26/1996 SUPPL-3 Labeling

Label is not available on this site.

07/31/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/24/1992 SUPPL-1 Labeling

Label is not available on this site.

NIFEDIPINE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 072579 ACTAVIS ELIZABETH
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 202644 HERITAGE PHARMA
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 072781 INTERGEL PHARM
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 073250 LEADING PHARMA LLC
PROCARDIA NIFEDIPINE 10MG CAPSULE;ORAL Prescription Yes AB 018482 PFIZER

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