Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016211
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIOCHOL ACETYLCHOLINE CHLORIDE 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FOR SOLUTION;OPHTHALMIC Discontinued None Yes No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
10/09/1973 ORIG-1 Approval Type 1 - New Molecular Entity 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
10/16/1996 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1996 SUPPL-23 Labeling

Label is not available on this site.

12/04/1987 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/31/1990 SUPPL-19 Labeling

Label is not available on this site.

09/04/1985 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/17/1988 SUPPL-17 Labeling

Label is not available on this site.

05/08/1984 SUPPL-16 Labeling

Label is not available on this site.

04/29/1985 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/06/1983 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/30/1987 SUPPL-13 Labeling

Label is not available on this site.

10/24/1986 SUPPL-12 Labeling

Label is not available on this site.

07/20/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1981 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/16/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1977 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

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