An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 016419
Company: BAXTER HLTHCARE CORP

Products on NDA 016419

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016419

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.

Labels for NDA 016419

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

Top