Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080027
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALCAINE PROPARACAINE HYDROCHLORIDE 0.5% 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
12/22/1971 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
04/04/2005 SUPPL-35 Labeling

Label is not available on this site.

08/06/2003 SUPPL-33 Labeling

Label is not available on this site.

12/23/2002 SUPPL-32 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/01/2001 SUPPL-31 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/01/2001 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

08/11/2000 SUPPL-29 Labeling

Label is not available on this site.

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

Label is not available on this site.

04/21/1999 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/07/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-24 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/11/2000 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/14/1996 SUPPL-22 Labeling

Label is not available on this site.

10/05/1995 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/04/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/05/1993 SUPPL-19 Labeling

Label is not available on this site.

06/04/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

12/21/1989 SUPPL-16 Labeling

Label is not available on this site.

05/17/1989 SUPPL-15 Labeling

Label is not available on this site.

04/27/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/17/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

ALCAINE

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALCAINE PROPARACAINE HYDROCHLORIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 080027 NOVARTIS PHARMS CORP
PROPARACAINE HYDROCHLORIDE PROPARACAINE HYDROCHLORIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040277 AKORN INC
PROPARACAINE HYDROCHLORIDE PROPARACAINE HYDROCHLORIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040074 BAUSCH AND LOMB

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