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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020237
Company: CONCORDIA

Products on NDA 020237

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020237

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/1994	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2015	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/26/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/18/2003	SUPPL-12	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020237s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20237scs012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020237_S012_SALAGEN_AP.pdf
09/04/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
02/04/2000	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/10/2002	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20237s8s9lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20237s008ltr.pdf
06/10/2002	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20237s8s9lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20237s008ltr.pdf
02/11/1998	SUPPL-7	Efficacy-New Indication	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20237s007_Salagen_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20237s007_Salagen.cfm
03/11/1997	SUPPL-6	Labeling		Label is not available on this site.
09/27/1996	SUPPL-5	Labeling		Label is not available on this site.
11/09/1995	SUPPL-4	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20327scs004ltr.pdf
11/09/1995	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
11/09/1995	SUPPL-2	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20137slr002LTR.pdf
04/18/1996	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020237

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2003	SUPPL-12	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020237s012lbl.pdf
06/10/2002	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20237s8s9lbl.pdf
06/10/2002	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20237s8s9lbl.pdf

Therapeutic Equivalents for NDA 020237

SALAGEN

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

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