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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087846
Company: SPECGX LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None Yes No
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Discontinued None Yes No
TOFRANIL IMIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/22/1984 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/29/2017 SUPPL-29 Labeling-Package Insert

Label is not available on this site.
07/17/2014 SUPPL-28 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087846s028,087844s027,087845s027lbl.pdf
09/27/2007 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/087844s025,087845s025,087846s026pi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/087844Orig1s025,087845Orig1s025,087846Orig1s026ltr.pdf
06/25/2007 SUPPL-25 Labeling

Label is not available on this site.
09/12/2005 SUPPL-23 Labeling

Label is not available on this site.
06/09/2005 SUPPL-22 Labeling

Label is not available on this site.
08/31/2004 SUPPL-21 Labeling

Label is not available on this site.
06/12/2002 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.
09/14/2000 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.
09/14/2000 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.
07/15/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
09/26/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
09/01/1998 SUPPL-15 Labeling

Label is not available on this site.
12/20/1994 SUPPL-13 Labeling

Label is not available on this site.
02/25/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
12/14/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
02/02/1993 SUPPL-10 Labeling

Label is not available on this site.
12/14/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
10/23/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
07/25/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
07/25/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/17/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087846s028,087844s027,087845s027lbl.pdf
09/27/2007 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/087844s025,087845s025,087846s026pi.pdf
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