Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020237
Company: CONCORDIA
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
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.

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

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 PERRIGO PHARMA INTL
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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