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Approved Drug Products containing 5213 listed in the FDA Orange Book. Original Data : FDA Website

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01 GENUS (2)

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01 SYRUP;ORAL (1)

02 TABLET;ORAL (1)

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01 RX (2)

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01 HYCODAN (2)

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01 Yes (2)

URL Supplier Web Content
TABLET; ORAL
1.5MG;5MG
1988-07-26
5213
HYCODAN
RX
Yes
AA
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URL Supplier Web Content
SYRUP; ORAL
1.5MG/5ML;5MG/5ML
1988-07-26
5213
HYCODAN
RX
Yes
AA
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 5213

Looking for FDA Orange Book APPLICATION 5213 2

19

Genus Lifesciences, based in U.S.A, is a pharmaceutical company.

One of their notable products is HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE, with a corresponding application number 5213.

Regulatory Information RX

With a dosage strength 1.5MG;5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1988-07-26

Therapeutic Equivalence (TE) Code AA

18

Genus Lifesciences, based in U.S.A, is a pharmaceutical company.

One of their notable products is HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE, with a corresponding application number 5213.

Regulatory Information RX

With a dosage strength 1.5MG/5ML;5MG/5ML

Dosage Form Route SYRUP; ORAL

Reference Listed Drug Yes

Approved since 1988-07-26

Therapeutic Equivalence (TE) Code AA

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