Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016419
Company: BAXTER HLTHCARE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Discontinued 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
11/13/1967 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/01/2008 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016419s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016419s029ltr.pdf
07/24/2006 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016419s026LTR.pdf
12/07/2001 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/06/2002 SUPPL-24 Labeling

Label is not available on this site.

02/14/2001 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/22/1999 SUPPL-22 Labeling

Label is not available on this site.

11/07/1997 SUPPL-21 Labeling

Label is not available on this site.

02/14/1990 SUPPL-20 Labeling

Label is not available on this site.

12/06/1988 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1988 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/18/1985 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1982 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1982 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1981 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/1978 SUPPL-13 Labeling

Label is not available on this site.

01/17/1979 SUPPL-12 Labeling

Label is not available on this site.

08/21/1978 SUPPL-9 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/01/2008 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016419s029lbl.pdf

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