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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074670
Company: ANI PHARMS

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
10/28/1996 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
09/26/2022 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.
07/17/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
08/14/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
08/14/1998 SUPPL-2 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 074670 ANI PHARMS
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE;ORAL Prescription No AB 217555 BIONPHARMA
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE;ORAL Prescription No AB 074928 EPIC PHARMA LLC
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE;ORAL Prescription No AB 216357 GLENMARK PHARMS LTD
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE;ORAL Prescription No AB 215377 SENORES PHARMS
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE;ORAL Prescription No AB 218202 SKG PHARMA

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 074670 ANI PHARMS
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 217555 BIONPHARMA
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 074928 EPIC PHARMA LLC
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 216357 GLENMARK PHARMS LTD
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 215377 SENORES PHARMS
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 218202 SKG PHARMA
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