Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017106
Company: MERIDIAN MEDCL TECHN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROPEN ATROPINE EQ 2MG SULFATE/0.7ML SOLUTION;INTRAMUSCULAR Prescription None Yes Yes
ATROPEN ATROPINE EQ 1MG SULFATE/0.7ML SOLUTION;INTRAMUSCULAR Prescription None Yes Yes
ATROPEN ATROPINE EQ 0.5MG SULFATE/0.7ML SOLUTION;INTRAMUSCULAR Prescription None Yes Yes
ATROPEN ATROPINE EQ 0.25MG SULFATE/0.3ML SOLUTION;INTRAMUSCULAR 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
05/15/1973 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2015 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.
05/27/2016 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.
11/14/2013 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.
09/17/2004 SUPPL-32 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17106s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17106s032ltr.pdf
06/19/2003 SUPPL-28 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17106se5-028_atroPen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17106se5-028ltr.pdf
06/28/2002 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
01/07/2002 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
03/04/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
06/08/2001 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
02/13/2001 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/31/2001 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/19/2000 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
08/16/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
08/18/2000 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
10/28/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
04/26/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
03/16/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
08/25/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
04/21/1998 SUPPL-14 Labeling

Label is not available on this site.
03/06/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
12/17/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
03/05/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
08/17/1990 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/04/1989 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
08/19/1987 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/06/1986 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/14/1985 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
06/06/1984 SUPPL-5 Labeling

Label is not available on this site.
12/27/1979 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
05/10/1979 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
07/27/1978 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
09/17/2004 SUPPL-32 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17106s032lbl.pdf
06/19/2003 SUPPL-28 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17106se5-028_atroPen_lbl.pdf

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