Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074439
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE;ORAL Prescription AB No No
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG 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
12/10/1996 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
04/12/2007 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

07/29/2002 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

11/29/1999 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

11/26/1999 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

11/10/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NICARDIPINE HYDROCHLORIDE

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE;ORAL Prescription No AB 074439 ANI PHARMS INC
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE;ORAL Prescription No AB 074540 ANI PHARMS INC
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE;ORAL Prescription No AB 074928 EPIC PHARMA
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE;ORAL Prescription No AB 074642 MYLAN

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 074439 ANI PHARMS INC
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 074540 ANI PHARMS INC
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 074928 EPIC PHARMA
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 074642 MYLAN

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