Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084110
Company: ALCON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOGYL CYCLOPENTOLATE HYDROCHLORIDE 1% SOLUTION/DROPS;OPHTHALMIC Prescription AT No 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
07/31/1974 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
10/31/2003 SUPPL-36 Labeling

Label is not available on this site.

12/23/2002 SUPPL-35 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/11/2002 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/2001 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/07/2000 SUPPL-32 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/28/2000 SUPPL-31 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/23/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/07/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-27 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/17/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/05/1995 SUPPL-25 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/04/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/04/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/03/1994 SUPPL-22 Labeling

Label is not available on this site.

01/16/1997 SUPPL-21 Labeling

Label is not available on this site.

12/02/1993 SUPPL-20 Labeling

Label is not available on this site.

11/05/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/29/1992 SUPPL-18 Labeling

Label is not available on this site.

06/04/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/04/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/20/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/20/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/13/1989 SUPPL-13 Labeling

Label is not available on this site.

08/28/1989 SUPPL-12 Labeling

Label is not available on this site.

03/09/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/20/1988 SUPPL-9 Labeling

Label is not available on this site.

12/08/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/12/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

CYCLOGYL

SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AKPENTOLATE CYCLOPENTOLATE HYDROCHLORIDE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040164 AKORN
CYCLOGYL CYCLOPENTOLATE HYDROCHLORIDE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 084110 ALCON LABS INC
PENTOLAIR CYCLOPENTOLATE HYDROCHLORIDE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040075 BAUSCH AND LOMB

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