Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012772
Company: LILLY
Company: LILLY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HALDRONE | PARAMETHASONE ACETATE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
HALDRONE | PARAMETHASONE ACETATE | 2MG | TABLET;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 |
---|---|---|---|---|---|---|---|
04/17/1961 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
01/09/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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01/09/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/27/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
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03/19/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
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08/22/1977 | SUPPL-4 | Labeling |
Label is not available on this site. |