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FDA ANDA · ANDA089464

HEPARIN SODIUM PRESERVATIVE FREE

Sponsor: DR REDDYS

APPLICATION
ANDA089464
TYPE
ANDA
ORIGINAL APPROVAL
1986-06-03
LATEST ACTION
2000-12-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

HEPARIN SODIUM PRESERVATIVE FREEDiscontinued
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION

Approval history

2000-12-08Manufacturing (CMC) · Supplement 17AP
1999-03-24Manufacturing (CMC) · Supplement 16AP
1998-03-26Labeling · Supplement 15AP
1997-01-28Labeling · Supplement 14AP
1996-08-16Labeling · Supplement 13AP
1996-04-11Labeling · Supplement 11AP
1996-03-13Manufacturing (CMC) · Supplement 12AP
1994-10-18Labeling · Supplement 9AP
1994-08-25Manufacturing (CMC) · Supplement 10AP
1993-07-30Manufacturing (CMC) · Supplement 6AP
1993-07-30Manufacturing (CMC) · Supplement 7AP
1993-07-30Labeling · Supplement 5AP
1992-05-12Manufacturing (CMC) · Supplement 8AP
1990-11-08Manufacturing (CMC) · Supplement 4AP
1988-10-27Labeling · Supplement 2AP
1988-10-27Labeling · Supplement 3AP
1988-03-30Manufacturing (CMC) · Supplement 1AP
1986-06-03OriginalAP
VIEW ON DRUGS@FDA ↗

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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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