Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016796
Company: AKORN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INAPSINE DROPERIDOL 2.5MG/ML 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
06/11/1970 ORIG-1 Approval Type 3 - New Dosage Form 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
11/26/2001 SUPPL-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16796s39ltr.pdf
12/14/2000 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/12/2000 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/2000 SUPPL-35 Labeling

Label is not available on this site.

09/29/1998 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1995 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/15/1995 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1994 SUPPL-30 Labeling

Label is not available on this site.

06/29/1994 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1992 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/05/1990 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1987 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/06/1988 SUPPL-25 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/15/1986 SUPPL-24 Labeling

Label is not available on this site.

12/15/1986 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1987 SUPPL-22 Labeling

Label is not available on this site.

03/15/1985 SUPPL-21 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/31/1987 SUPPL-20 Labeling

Label is not available on this site.

12/31/1987 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/20/1982 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1982 SUPPL-13 Labeling

Label is not available on this site.

07/28/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1980 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1976 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1974 SUPPL-5 Labeling

Label is not available on this site.

INAPSINE

INJECTABLE;INJECTION; 2.5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DROPERIDOL DROPERIDOL 2.5MG/ML INJECTABLE;INJECTION Prescription No AP 208197 EUROHLTH INTL SARL
DROPERIDOL DROPERIDOL 2.5MG/ML INJECTABLE;INJECTION Prescription No AP 071981 HOSPIRA
DROPERIDOL DROPERIDOL 2.5MG/ML INJECTABLE;INJECTION Prescription No AP 072123 LUITPOLD
INAPSINE DROPERIDOL 2.5MG/ML INJECTABLE;INJECTION Prescription Yes AP 016796 AKORN INC

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