Drugs@FDA: FDA-Approved Drugs
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | 5,000 UNITS/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | 10,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | 20,000 UNITS/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | 15,000 UNITS/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 |
|---|---|---|---|---|---|---|---|
| 03/05/1973 | 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 |
|---|---|---|---|---|---|
| 10/02/2023 | SUPPL-66 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017067Orig1s066ltr.pdf |
| 09/10/2015 | SUPPL-62 | Supplement |
Label is not available on this site. |
||
| 01/29/2014 | SUPPL-60 | Supplement |
Label is not available on this site. |
||
| 02/16/2013 | SUPPL-59 | Supplement |
Label is not available on this site. |
||
| 04/15/2011 | SUPPL-57 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017067s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017067s057ltr.pdf | |
| 11/14/2002 | SUPPL-54 | Supplement |
Label is not available on this site. |
||
| 03/06/1997 | SUPPL-52 | Supplement |
Label is not available on this site. |
||
| 02/11/1993 | SUPPL-51 | Supplement |
Label is not available on this site. |
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| 08/15/1991 | SUPPL-50 | Supplement |
Label is not available on this site. |
||
| 08/14/1991 | SUPPL-49 | Supplement |
Label is not available on this site. |
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| 08/05/1987 | SUPPL-47 | Supplement |
Label is not available on this site. |
||
| 01/10/1986 | SUPPL-46 | Supplement |
Label is not available on this site. |
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| 05/16/1984 | SUPPL-45 | Supplement |
Label is not available on this site. |
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| 10/20/1982 | SUPPL-44 | Supplement |
Label is not available on this site. |
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| 02/03/1982 | SUPPL-43 | Supplement |
Label is not available on this site. |
||
| 07/13/1981 | SUPPL-42 | Supplement |
Label is not available on this site. |
||
| 12/18/1979 | SUPPL-39 | Supplement |
Label is not available on this site. |
||
| 08/13/1980 | SUPPL-38 | Supplement |
Label is not available on this site. |
||
| 08/13/1980 | SUPPL-37 | Supplement |
Label is not available on this site. |
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| 08/13/1980 | SUPPL-35 | Supplement |
Label is not available on this site. |
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| 12/18/1979 | SUPPL-34 | Supplement |
Label is not available on this site. |
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| 08/13/1980 | SUPPL-33 | Supplement |
Label is not available on this site. |
||
| 08/13/1980 | SUPPL-32 | Supplement |
Label is not available on this site. |
||
| 12/18/1979 | SUPPL-31 | Supplement |
Label is not available on this site. |
||
| 08/13/1980 | SUPPL-30 | Supplement |
Label is not available on this site. |
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| 08/13/1980 | SUPPL-29 | Supplement |
Label is not available on this site. |
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| 12/18/1979 | SUPPL-28 | Supplement |
Label is not available on this site. |
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| 12/18/1979 | SUPPL-27 | Supplement |
Label is not available on this site. |
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| 03/09/1978 | SUPPL-25 | Supplement |
Label is not available on this site. |
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| 03/09/1978 | SUPPL-24 | Supplement |
Label is not available on this site. |
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| 03/09/1978 | SUPPL-23 | Supplement |
Label is not available on this site. |
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| 07/22/1980 | SUPPL-22 | Supplement |
Label is not available on this site. |
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| 12/18/1979 | SUPPL-21 | Supplement |
Label is not available on this site. |
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| 07/22/1980 | SUPPL-20 | Supplement |
Label is not available on this site. |
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| 07/22/1980 | SUPPL-19 | Supplement |
Label is not available on this site. |
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| 03/09/1978 | SUPPL-17 | Supplement |
Label is not available on this site. |
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| 12/18/1979 | SUPPL-15 | Supplement |
Label is not available on this site. |
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| 07/22/1980 | SUPPL-11 | Supplement |
Label is not available on this site. |
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| 07/22/1980 | SUPPL-10 | Supplement |
Label is not available on this site. |
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| 07/22/1980 | SUPPL-9 | Supplement |
Label is not available on this site. |
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| 12/18/1979 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 07/22/1980 | SUPPL-2 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/15/2011 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017067s057lbl.pdf |