Orange Book product · Generic (ANDA)
RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE
At a glance
Sep 21, 2007
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 21, 2007
19 yr ago
Today
Pharmaceutical detail
Active ingredient
RANITIDINE HYDROCHLORIDE
Strength
EQ 15MG BASE/ML
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
ANDA 077405
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of RANITIDINE HYDROCHLORIDE
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- 1988ZANTACBrand (NDA)
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- 2017RANITIDINE HYDROCHLORIDEGeneric (ANDA)
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- 2017RANITIDINE HYDROCHLORIDEGeneric (ANDA)
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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.
