Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018243
Company: WEST-WARD PHARMS INT
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/29/1980 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
05/09/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/10/2007 SUPPL-13 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

03/22/1995 SUPPL-12 Labeling

Label is not available on this site.

12/23/1993 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1993 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/1990 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1988 SUPPL-8 Labeling

Label is not available on this site.

07/14/1987 SUPPL-7 Labeling

Label is not available on this site.

09/24/1987 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/28/1986 SUPPL-5 Labeling

Label is not available on this site.

01/31/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1983 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1984 SUPPL-2 Labeling

Label is not available on this site.

08/14/1980 SUPPL-1 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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