Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH AND LOMB INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LACRISERT | HYDROXYPROPYL CELLULOSE | 5MG | INSERT;OPHTHALMIC | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
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. |
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11/19/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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11/01/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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11/01/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
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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 |