An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076963
Company: INNOGENIX

Products on ANDA 076963

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	No
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076963

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2004	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
08/26/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/16/2008	SUPPL-5	Labeling		Label is not available on this site.
02/27/2007	SUPPL-2	Manufacturing (CMC)-New Strength		Label is not available on this site.
02/27/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076963

PILOCARPINE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	212377	AUROBINDO PHARMA LTD
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	077248	IMPAX LABS
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076963	INNOGENIX
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	077220	LANNETT CO INC
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076746	PADAGIS US
SALAGEN	PILOCARPINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	Yes	AB	020237	CONCORDIA

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET;ORAL	Prescription	No	AB	212377	AUROBINDO PHARMA LTD
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET;ORAL	Prescription	No	AB	077248	IMPAX LABS
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET;ORAL	Prescription	No	AB	076963	INNOGENIX
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET;ORAL	Prescription	No	AB	077220	LANNETT CO INC
SALAGEN	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET;ORAL	Prescription	Yes	AB	020237	CONCORDIA

Top