Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020213
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.

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.

08/18/1995 SUPPL-2 Labeling

Label is not available on this site.

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

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