Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050493
Company: SHIRE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPICYCLINE TETRACYCLINE HYDROCHLORIDE 2.2MG/ML FOR SOLUTION;TOPICAL 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
09/21/1977 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/17/1997 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/23/1997 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/27/1986 SUPPL-29 Labeling

Label is not available on this site.

01/17/1983 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/22/1982 SUPPL-27 Labeling

Label is not available on this site.

12/01/1981 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/30/1981 SUPPL-25 Labeling

Label is not available on this site.

08/10/1981 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1982 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/13/1981 SUPPL-22 Labeling

Label is not available on this site.

02/02/1981 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1980 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/22/1979 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/03/1979 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1979 SUPPL-17 Labeling

Label is not available on this site.

03/28/1979 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/26/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1978 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/25/1978 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1978 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1978 SUPPL-10 Labeling

Label is not available on this site.

04/11/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1978 SUPPL-8 Labeling

Label is not available on this site.

01/24/1978 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/11/1978 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1986 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/27/1977 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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