Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 017835
Company: ISO TEX
Company: ISO TEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHROMALBIN | ALBUMIN CHROMATED CR-51 SERUM | 100uCi/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CHROMALBIN | ALBUMIN CHROMATED CR-51 SERUM | 250uCi/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CHROMALBIN | ALBUMIN CHROMATED CR-51 SERUM | 500uCi/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/23/1976 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/17/1986 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 07/29/1981 | SUPPL-7 | Supplement |
Label is not available on this site. |
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| 03/08/1979 | SUPPL-6 | Supplement |
Label is not available on this site. |
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| 03/08/1979 | SUPPL-5 | Supplement |
Label is not available on this site. |
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| 02/28/1978 | SUPPL-4 | Supplement |
Label is not available on this site. |
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| 02/28/1978 | SUPPL-2 | Supplement |
Label is not available on this site. |
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| 07/16/1976 | SUPPL-1 | Supplement |
Label is not available on this site. |