Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 061837
Company: WATSON LABS

Products on ANDA 061837

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	AB	No	No
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 061837

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/24/1974	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
05/20/2002	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
12/21/1999	SUPPL-23	Manufacturing (CMC)-Facility		Label is not available on this site.
11/10/1999	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
11/10/1999	SUPPL-21	Manufacturing (CMC)-Facility		Label is not available on this site.
10/01/1999	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
10/01/1999	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/20/1999	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
07/30/1998	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/10/1997	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/08/1996	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/16/1991	SUPPL-8	Labeling		Label is not available on this site.
02/14/1989	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 061837

TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	210674	AMNEAL PHARMS NY
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	210662	BRECKENRIDGE
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	062752	CHARTWELL TETRA
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	212635	STRIDES PHARMA
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	061837	WATSON LABS

CAPSULE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	No	AB	210674	AMNEAL PHARMS NY
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	No	AB	210662	BRECKENRIDGE
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	No	AB	062752	CHARTWELL TETRA
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	No	AB	212635	STRIDES PHARMA
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	No	AB	061837	WATSON LABS