Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016750
Company: AMPHASTAR PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTROSYN COSYNTROPIN 0.25MG/VIAL INJECTABLE;INJECTION Prescription AP 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
04/22/1970 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
09/29/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/05/2002 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16750slr018ltr.pdf
12/07/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1998 SUPPL-15 Labeling

Label is not available on this site.

01/29/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/08/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/28/1989 SUPPL-10 Labeling

Label is not available on this site.

10/28/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/09/1988 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1987 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1987 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1986 SUPPL-4 Labeling

Label is not available on this site.

10/26/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/28/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

CORTROSYN

INJECTABLE;INJECTION; 0.25MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORTROSYN COSYNTROPIN 0.25MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 016750 AMPHASTAR PHARMS INC
COSYNTROPIN COSYNTROPIN 0.25MG/VIAL INJECTABLE;INJECTION Prescription No AP 090574 MYLAN INSTITUTIONAL
COSYNTROPIN COSYNTROPIN 0.25MG/VIAL INJECTABLE;INJECTION Prescription No AP 202147 SANDOZ

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