Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017638
Company: ABBOTT
Company: ABBOTT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THYPINONE | 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 |
|---|---|---|---|---|---|---|---|
| 11/05/1976 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/25/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/07/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 02/14/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/24/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 07/16/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/09/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/12/1977 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |