Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
01/29/1974 | 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 |
---|---|---|---|---|---|
09/27/2004 | SUPPL-218 | Labeling |
Label is not available on this site. |
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06/09/2003 | SUPPL-215 | Labeling |
Label is not available on this site. |
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11/20/2002 | SUPPL-210 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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02/19/1999 | SUPPL-208 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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02/02/1999 | SUPPL-207 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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12/04/1996 | SUPPL-206 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/06/1992 | SUPPL-205 | Manufacturing (CMC) |
Label is not available on this site. |
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01/11/1991 | SUPPL-204 | Labeling |
Label is not available on this site. |
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04/09/1990 | SUPPL-203 | Labeling |
Label is not available on this site. |
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10/12/1989 | SUPPL-202 | Labeling |
Label is not available on this site. |
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10/12/1989 | SUPPL-201 | Labeling |
Label is not available on this site. |
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04/11/1989 | SUPPL-200 | Manufacturing (CMC) |
Label is not available on this site. |
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04/11/1989 | SUPPL-199 | Manufacturing (CMC) |
Label is not available on this site. |
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08/03/1988 | SUPPL-196 | Manufacturing (CMC) |
Label is not available on this site. |
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08/03/1988 | SUPPL-195 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1986 | SUPPL-191 | Manufacturing (CMC) |
Label is not available on this site. |
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11/03/1982 | SUPPL-187 | Manufacturing (CMC) |
Label is not available on this site. |
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04/23/1982 | SUPPL-184 | Manufacturing (CMC) |
Label is not available on this site. |
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04/23/1982 | SUPPL-155 | Manufacturing (CMC) |
Label is not available on this site. |