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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074928
Company: EPIC PHARMA LLC

Products on ANDA 074928

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074928

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/17/2025	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/17/2002	SUPPL-5	Labeling		Label is not available on this site.
12/15/1999	SUPPL-4	Labeling		Label is not available on this site.
12/01/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 074928

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928ap_appltr_prntlbl_chemr.pdf

Therapeutic Equivalents for ANDA 074928

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	218202	AMNEAL
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

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	218202	AMNEAL
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

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