Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050268
Company: STORZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACHROMYCIN TETRACYCLINE HYDROCHLORIDE 1% SUSPENSION/DROPS;OPHTHALMIC 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
11/23/1955 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
12/01/1988 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1982 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1981 SUPPL-28 Labeling

Label is not available on this site.

03/20/1981 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1975 SUPPL-26 Labeling

Label is not available on this site.

10/06/1975 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1975 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/13/1975 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1974 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/06/1974 SUPPL-21 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/09/1974 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/28/1972 SUPPL-19 Labeling

Label is not available on this site.

06/12/1970 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/05/1968 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/20/1965 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/25/1965 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1963 SUPPL-14 Labeling

Label is not available on this site.

02/20/1962 SUPPL-13 Labeling

Label is not available on this site.

06/28/1991 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1961 SUPPL-10 Labeling

Label is not available on this site.

02/20/1962 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/27/1986 SUPPL-8 Labeling

Label is not available on this site.

03/17/1961 SUPPL-7 Labeling

Label is not available on this site.

05/23/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/13/1985 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/21/1983 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/22/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1982 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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