Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020213
Company: BAUSCH AND LOMB
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIOCHOL-E | ACETYLCHOLINE CHLORIDE | 20MG/VIAL | FOR SOLUTION;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 |
---|---|---|---|---|---|---|---|
09/22/1993 | 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 |
---|---|---|---|---|---|
06/17/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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05/30/2006 | SUPPL-10 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020213s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020213s010LTR.pdf | |
01/24/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/29/1998 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
10/16/1996 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/18/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
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02/29/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/30/2006 | SUPPL-10 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020213s010lbl.pdf |