Drugs@FDA: FDA-Approved Drugs
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. |
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| 10/13/1988 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 11/03/1987 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/03/1987 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/22/1988 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 11/06/1986 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 11/05/1987 | SUPPL-35 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 06/16/1986 | SUPPL-34 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 03/19/1986 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/20/1986 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/22/1985 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 11/21/1985 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 08/24/1984 | SUPPL-28 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 08/22/1984 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/11/1984 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 03/29/1985 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/19/1983 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/19/1983 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 04/25/1983 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/13/1987 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 04/15/1980 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 01/15/1980 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 06/08/1978 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/15/1977 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/12/1977 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/28/1975 | SUPPL-10 | Efficacy |
Label is not available on this site. |