Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062653
Company: WARNER CHILCOTT
Company: WARNER CHILCOTT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DORYX | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE, DELAYED RELEASE;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 |
---|---|---|---|---|---|---|---|
10/30/1985 | 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 |
---|---|---|---|---|---|
03/26/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
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11/10/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/11/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/23/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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02/06/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/31/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |