APPLICATION
ANDA070690
TYPE
ANDA
ORIGINAL APPROVAL
1987-05-15
LATEST ACTION
2017-06-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 40MG/5ML · SOLUTION · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 20MG/5ML · SOLUTION · ORAL
Approval history
2017-06-16Labeling · Supplement 21 · standardAP
2008-09-10Labeling · Supplement 20AP
2008-07-09Labeling · Supplement 19AP
2007-06-21Labeling · Supplement 17AP
2004-06-09Labeling · Supplement 14AP
2001-08-01Labeling · Supplement 13AP
1999-08-12Manufacturing (CMC) · Supplement 11AP
1998-10-23Manufacturing (CMC) · Supplement 12AP
1996-08-28Manufacturing (CMC) · Supplement 9AP
1994-01-05Labeling · Supplement 8AP
1991-05-16Labeling · Supplement 7AP
1990-10-09Labeling · Supplement 6AP
1990-04-04Labeling · Supplement 5AP
1990-01-08Labeling · Supplement 1AP
1989-09-25Manufacturing (CMC) · Supplement 4AP
1989-01-24Manufacturing (CMC) · Supplement 2AP
1989-01-24Manufacturing (CMC) · Supplement 3AP
1987-05-15OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.