Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075613
Company: INVATECH

• Other Important Information from FDA

Products on ANDA 075613

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Discontinued	None	No	No
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075613

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75613ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-613_Bupropiion%20Hydrochloride.pdf