Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070792
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE; ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
05/13/1986 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/25/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
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02/25/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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02/05/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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07/05/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/19/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
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06/22/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
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07/11/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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10/28/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DOXEPIN HYDROCHLORIDE
CAPSULE; ORAL; EQ 75MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE; ORAL | Prescription | No | AB | 070792 | MYLAN |