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Drugs@FDA: FDA-Approved Drugs

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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
12/22/2023 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016750s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/016750Orig1s033ltr.pdf
12/14/2021 SUPPL-32 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016750Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/016750Orig1s032ltr.pdf
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/22/2023 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016750s033lbl.pdf
12/14/2021 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016750Orig1s032lbl.pdf
12/14/2021 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016750Orig1s032lbl.pdf

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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