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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050278
Company: AVET
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACHROMYCIN V TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Discontinued None Yes Yes
ACHROMYCIN V TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Discontinued None Yes 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
10/08/1957 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/19/2016 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

07/21/2016 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

04/27/2015 SUPPL-37 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050278s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050278Orig1s037ltr.pdf
04/21/2015 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/17/1999 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/26/1961 SUPPL-32 Labeling

Label is not available on this site.

03/16/1961 SUPPL-31 Labeling

Label is not available on this site.

01/16/1961 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1960 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/02/1960 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1959 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/13/1959 SUPPL-25 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/01/1958 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/15/1958 SUPPL-23 Labeling

Label is not available on this site.

09/15/1958 SUPPL-22 Labeling

Label is not available on this site.

05/28/1958 SUPPL-21 Labeling

Label is not available on this site.

04/25/1958 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/15/1992 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/15/1991 SUPPL-12 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/27/2015 SUPPL-37 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050278s037lbl.pdf
04/27/2015 SUPPL-37 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050278s037lbl.pdf
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