Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018248
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYTOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
OXYTOCIN OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
OXYTOCIN OXYTOCIN 300USP UNITS/30ML (10USP UNITS/ML) INJECTABLE;INJECTION 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
07/09/1980 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
09/10/2014 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

07/27/2007 SUPPL-34 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018248s034_ltr.pdf
10/11/2000 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/31/2000 SUPPL-27 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018248_S027_OXYTOCIN_AP.pdf
02/22/1999 SUPPL-26 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018248_S026_OXYTOCIN_AP.pdf
07/02/1999 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/23/1994 SUPPL-23 Labeling

Label is not available on this site.

01/13/1995 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/16/1994 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

01/20/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/16/1988 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1987 SUPPL-17 Labeling

Label is not available on this site.

09/19/1986 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1986 SUPPL-15 Labeling

Label is not available on this site.

03/14/1985 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1984 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1983 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1983 SUPPL-11 Labeling

Label is not available on this site.

11/12/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1983 SUPPL-8 Labeling

Label is not available on this site.

03/10/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

OXYTOCIN

INJECTABLE;INJECTION; 10USP UNITS/ML (10USP UNITS/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYTOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018248 FRESENIUS KABI USA
OXYTOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription No AP 200219 HIKMA FARMACEUTICA
OXYTOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription No AP 091676 SAGENT PHARMS INC
OXYTOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018243 WEST-WARD PHARMS INT
PITOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018261 PAR STERILE PRODUCTS

INJECTABLE;INJECTION; 100USP UNITS/10ML (10USP UNITS/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYTOCIN OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018248 FRESENIUS KABI USA
OXYTOCIN OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription No AP 091676 SAGENT PHARMS INC
OXYTOCIN OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018243 WEST-WARD PHARMS INT
PITOCIN OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription Yes AP 018261 PAR STERILE PRODUCTS

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