Drugs@FDA: FDA-Approved Drugs

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

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