Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065041
Company: WATSON LABS

Products on ANDA 065041

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Discontinued	None	No	No
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065041

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65041ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2002	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
02/20/2002	SUPPL-13	Labeling		Label is not available on this site.
07/24/2002	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
02/08/2002	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
09/24/2001	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
11/02/2001	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
08/23/2001	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
11/14/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.