Drugs@FDA: FDA-Approved Drugs
Company: MYLAN SPECIALITY LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METAPROTERENOL SULFATE | METAPROTERENOL SULFATE | 0.6% | SOLUTION;INHALATION | 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 |
---|---|---|---|---|---|---|---|
08/17/1987 | 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 |
---|---|---|---|---|---|
05/26/2004 | SUPPL-19 | Labeling |
Label is not available on this site. |
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04/01/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
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12/20/2002 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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12/20/2002 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/03/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/17/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
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04/21/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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07/16/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
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03/13/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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04/13/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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04/13/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |