Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018087
Company: FERRING
Company: FERRING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THYREL TRH | PROTIRELIN | 0.5MG/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 |
|---|---|---|---|---|---|---|---|
| 07/18/1978 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 06/23/1994 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 07/21/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/23/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/03/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 07/01/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/03/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 11/13/1984 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/10/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/28/1983 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/15/1979 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |