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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207389
Company: INVAGEN PHARMS

Products on ANDA 207389

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	AB	No	No
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207389

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2023	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/08/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/29/2020	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 207389

BUPROPION HYDROCHLORIDE

TABLET;ORAL; 75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	203013	ALEMBIC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	075584	APNAR PHARMA LP
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	076143	APOTEX INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	208606	CADILA PHARMS LTD
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	206975	HERITAGE PHARMA
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	207389	INVAGEN PHARMS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	207403	MICRO LABS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	203013	ALEMBIC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075584	APNAR PHARMA LP
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	076143	APOTEX INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	208606	CADILA PHARMS LTD
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	206975	HERITAGE PHARMA
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	207389	INVAGEN PHARMS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	207403	MICRO LABS

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