Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018261
Company: PAR STERILE PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PITOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
PITOCIN OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription AP Yes No
PITOCIN OXYTOCIN 500USP UNITS/50ML (10USP UNITS/ML) INJECTABLE;INJECTION Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/19/1980 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
08/15/2016 SUPPL-33 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/18/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

10/02/2014 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018261s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018261Orig1s031ltr.pdf
07/27/2007 SUPPL-28 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018261s028ltr.pdf
03/24/2003 SUPPL-23 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18261slr023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018261_s023_PITOCIN_LBL.pdf
09/24/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/2002 SUPPL-21 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18261s21ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018261_s021_PITOCIN_LBL.pdf
03/08/2001 SUPPL-20 Labeling

Label is not available on this site.

03/08/2001 SUPPL-19 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/08/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/2000 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/01/2000 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/10/1999 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1999 SUPPL-13 Labeling

Label is not available on this site.

07/10/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1997 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18261-s011_pitocin.pdf
02/22/1996 SUPPL-9 Labeling

Label is not available on this site.

05/27/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1994 SUPPL-7 Labeling

Label is not available on this site.

08/09/1994 SUPPL-6 Labeling

Label is not available on this site.

07/03/1990 SUPPL-5 Labeling

Label is not available on this site.

02/16/1988 SUPPL-4 Labeling

Label is not available on this site.

01/29/1987 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1986 SUPPL-2 Labeling

Label is not available on this site.

01/27/1984 SUPPL-1 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
10/02/2014 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018261s031lbl.pdf
07/27/2007 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf
07/27/2007 SUPPL-28 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf

PITOCIN

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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