Orange Book product · Generic (ANDA)
PROCAINAMIDE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDE
At a glance
Dec 13, 1996
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 1996
29 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
PROCAINAMIDE HYDROCHLORIDE
Strength
1GM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 040111
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PROCAINAMIDE HYDROCHLORIDE
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ANDA 089528 · WARNER CHILCOTT
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ANDA 089529 · WARNER CHILCOTT
- 1987PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089537 · HOSPIRA
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ANDA 089415 · ABRAXIS PHARM
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ANDA 089416 · ABRAXIS PHARM
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ANDA 089219 · ANI PHARMS
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ANDA 089029 · HIKMA
- 1986PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089030 · WEST-WARD PHARMS INT
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
