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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018771
Company: BAUSCH AND LOMB INC

Products on NDA 018771

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LACRISERT	HYDROXYPROPYL CELLULOSE	5MG	INSERT;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018771

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.

Labels for NDA 018771

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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