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FDA ANDA · ANDA075826
PROPRANOLOL
propranolol hydrochloride
Sponsor: FRESENIUS KABI USA
APPLICATION
ANDA075826
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-31
LATEST ACTION
2007-11-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 1MG/ML · INJECTABLE · INJECTION
Approval history
2007-11-07Labeling · Supplement 7AP
2002-04-03Labeling · Supplement 4AP
2002-02-19Manufacturing (CMC) · Supplement 3AP
2002-02-19Manufacturing (CMC) · Supplement 1AP
2002-02-19Manufacturing (CMC) · Supplement 2AP
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.
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