Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050638
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER PENICILLIN G POTASSIUM 20,000 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER PENICILLIN G POTASSIUM 40,000 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER PENICILLIN G POTASSIUM 60,000 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
06/25/1990 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
11/27/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050638s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050638Orig1s020ltr.pdf
07/18/2016 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050638s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050638Orig1s019ltr.pdf
03/19/2014 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/16/2012 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050638s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050638s016ltr.pdf
03/01/2008 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050638s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050638s012ltr.pdf
02/04/2005 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50638s011ltr.pdf
06/10/2004 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50638slr010ltr.pdf
11/07/2000 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/23/2002 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50638slr007ltr.pdf
07/20/1999 SUPPL-6 Labeling

Label is not available on this site.

10/31/1994 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1991 SUPPL-2 Labeling

Label is not available on this site.

11/03/1992 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
11/27/2017 SUPPL-20 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050638s020lbl.pdf
07/18/2016 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050638s019lbl.pdf
04/16/2012 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050638s016lbl.pdf
03/01/2008 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050638s012lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English