Drugs@FDA: FDA-Approved Drugs
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 | 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 |