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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212377
Company: AUROBINDO PHARMA USA

Products on ANDA 212377

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 212377

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212377

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 USA
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
SALAGEN	PILOCARPINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	Yes	AB	020237	ADVANZ PHARMA

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 USA
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	ADVANZ PHARMA

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