Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 003977
Company: PARKEDALE
Company: PARKEDALE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THEELIN | ESTRONE | 1MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
THEELIN | ESTRONE | 2MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
THEELIN | ESTRONE | 5MG/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 |
---|---|---|---|---|---|---|---|
06/12/1941 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/19/1988 | SUPPL-13 | Labeling |
Label is not available on this site. |
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05/17/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
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12/29/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
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04/07/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
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09/29/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
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03/27/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
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10/20/1978 | SUPPL-4 | Labeling |
Label is not available on this site. |
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03/27/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
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03/27/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |