Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085223
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription AB No 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
08/17/1976 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
11/27/2013 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

08/13/2013 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

12/31/2012 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

03/25/1998 SUPPL-39 Labeling

Label is not available on this site.

07/16/1997 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/16/1997 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/19/1996 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/19/1996 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/19/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/26/1995 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/11/1994 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/12/1991 SUPPL-31 Labeling

Label is not available on this site.

08/23/1990 SUPPL-26 Labeling

Label is not available on this site.

03/15/1990 SUPPL-25 Labeling

Label is not available on this site.

03/31/1989 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/31/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/15/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/30/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/04/1986 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/06/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/06/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/13/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/26/1979 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

DICYCLOMINE HYDROCHLORIDE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENTYL DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription Yes AB 007409 ALLERGAN
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040161 HIKMA PHARMS
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040230 LANNETT
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040317 MYLAN
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 085223 WATSON LABS

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