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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075124
Company: MYLAN

Products on ANDA 075124

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075124

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2011	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
01/27/2011	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/27/2005	SUPPL-9	Labeling		Label is not available on this site.
03/24/2004	SUPPL-8	Labeling		Label is not available on this site.
08/07/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
11/07/2000	SUPPL-2	Labeling		Label is not available on this site.
02/05/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 075124

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124ap_appltr_prntlbl_chemr.pdf

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