Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018771
Company: ATON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACRISERT HYDROXYPROPYL CELLULOSE 5MG INSERT;OPHTHALMIC Prescription None 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
06/01/1981 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2008 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

02/21/2008 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018771s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018771s017ltr.pdf
11/22/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/2002 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18771S12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18771s12ltr.pdf
06/02/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1997 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/15/1997 SUPPL-9 Labeling

Label is not available on this site.

08/21/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1994 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/19/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-4 Labeling

Label is not available on this site.

11/01/1988 SUPPL-3 Labeling

Label is not available on this site.

01/21/1983 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/21/1983 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
02/21/2008 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018771s017lbl.pdf
03/20/2002 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18771S12lbl.pdf

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