Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060736
Company: SUN PHARM INDUSTRIES

Products on ANDA 060736

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Discontinued	None	No	No
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 060736

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/1980	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2025	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
07/24/2002	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
02/08/2002	SUPPL-22	Manufacturing (CMC)-Facility		Label is not available on this site.
09/24/2001	SUPPL-21	Manufacturing (CMC)-Facility		Label is not available on this site.
11/02/2001	SUPPL-20	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-19	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-17	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-16	Manufacturing (CMC)-Facility		Label is not available on this site.
05/01/1992	SUPPL-15	Labeling		Label is not available on this site.
01/22/1992	SUPPL-14	Labeling		Label is not available on this site.