Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076746
Company: PADAGIS US

Products on ANDA 076746

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076746

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76746ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2011	SUPPL-2	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
06/29/2005	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076746

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	076963	AMICI
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	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