Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016987
Company: NEW RIVER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Discontinued None No No
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Discontinued None No No
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Discontinued None No No
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Discontinued None No No
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Discontinued None No No
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 150MG 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
01/31/1972 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
06/19/1990 SUPPL-44 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/13/1988 SUPPL-42 Labeling

Label is not available on this site.

11/03/1987 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/03/1987 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/1988 SUPPL-37 Labeling

Label is not available on this site.

11/06/1986 SUPPL-36 Labeling

Label is not available on this site.

11/05/1987 SUPPL-35 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/16/1986 SUPPL-34 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/19/1986 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/20/1986 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/1985 SUPPL-31 Labeling

Label is not available on this site.

11/21/1985 SUPPL-29 Labeling

Label is not available on this site.

08/24/1984 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/22/1984 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/1984 SUPPL-26 Labeling

Label is not available on this site.

03/29/1985 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1983 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/19/1983 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/25/1983 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1987 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/15/1980 SUPPL-16 Labeling

Label is not available on this site.

01/15/1980 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/08/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1977 SUPPL-13 Labeling

Label is not available on this site.

12/12/1977 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1975 SUPPL-10 Efficacy

Label is not available on this site.

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