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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075366
Company: UPSHER SMITH LABS

Products on ANDA 075366

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Discontinued	None	No	No
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Discontinued	None	No	No
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Discontinued	None	No	No
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	240MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075366

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75366ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75366ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2015	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
12/18/2015	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
09/18/2002	SUPPL-5	Labeling		Label is not available on this site.
04/30/2002	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
10/25/2000	SUPPL-3	Labeling		Label is not available on this site.
09/07/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
09/07/2000	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 075366

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol%20Hydrochloride_prntlbl.pdf

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