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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018261
Company: PH HEALTH

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/11/2021 SUPPL-41 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018261Orig1s041lbl.pdf
05/11/2021 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018261Orig1s041lbl.pdf
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf
07/27/2007 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf
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