Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018245
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNTOCINON OXYTOCIN 10USP UNITS/ML INJECTABLE;INJECTION Discontinued None No 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
04/17/1980 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
04/29/1997 SUPPL-22 Labeling

Label is not available on this site.

05/13/1997 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/14/1994 SUPPL-19 Labeling

Label is not available on this site.

01/21/1993 SUPPL-18 Labeling

Label is not available on this site.

06/08/1992 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/24/1986 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1984 SUPPL-9 Labeling

Label is not available on this site.

02/04/1986 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/06/1984 SUPPL-6 Labeling

Label is not available on this site.

12/07/1983 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1981 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/18/1980 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/09/1980 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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