Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008845
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUELICIN | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| QUELICIN PRESERVATIVE FREE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| QUELICIN PRESERVATIVE FREE | SUCCINYLCHOLINE CHLORIDE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| QUELICIN PRESERVATIVE FREE | SUCCINYLCHOLINE CHLORIDE | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/01/1953 | 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 |
|---|---|---|---|---|---|
| 11/01/2022 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008845s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/008845Orig1s080ltr.pdf | |
| 02/17/2022 | SUPPL-79 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008845Orig1s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/008845Orig1s079ltr.pdf | |
| 08/11/2021 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008845s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/008845Orig1s076ltr.pdf | |
| 07/26/2018 | SUPPL-73 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008845s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008845Orig1s073Ltr.pdf | |
| 07/30/2014 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/2013 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/2010 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008845s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/008845s065ltr.pdf | |
| 12/17/2002 | SUPPL-55 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/17/2000 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/2000 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 01/29/1999 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 05/26/1998 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1999 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 10/27/1997 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/28/1994 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 05/03/1989 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 05/03/1989 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/27/1988 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/16/1987 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/01/1987 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 09/01/1987 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 09/01/1987 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/27/1984 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1982 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 10/23/1981 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/10/1981 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1981 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1981 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/03/1980 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1982 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 09/03/1980 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/1980 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1981 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/1980 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/11/1979 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/22/1978 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/1978 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/1977 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/06/1977 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 09/06/1977 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1976 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/14/1976 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/20/1976 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/14/1976 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/06/1976 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/06/1976 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/22/1976 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/01/2022 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008845s080lbl.pdf | |
| 02/17/2022 | SUPPL-79 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008845Orig1s079lbl.pdf | |
| 08/11/2021 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008845s076lbl.pdf | |
| 07/26/2018 | SUPPL-73 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008845s073lbl.pdf | |
| 07/26/2018 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008845s073lbl.pdf | |
| 11/22/2010 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008845s065lbl.pdf |
QUELICIN
INJECTABLE;INJECTION; 20MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANECTINE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 008453 | SANDOZ |
| QUELICIN | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 008845 | HOSPIRA |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211432 | AMNEAL |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210231 | AMRING PHARMS |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213810 | ASPIRO |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 218878 | BAXTER HLTHCARE CORP |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216003 | BE PHARMS |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214491 | DEVA HOLDING AS |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210698 | DR REDDYS |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211346 | FRESENIUS KABI USA |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217885 | FRESENIUS KABI USA |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214246 | GLAND |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213229 | HIKMA |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214514 | MEITHEAL |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214879 | MICRO LABS |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214308 | REGCON HOLDINGS |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215022 | SAGENT PHARMS INC |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211589 | SOMERSET THERAPS LLC |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211625 | UMEDICA |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209467 | ZYDUS PHARMS |
QUELICIN PRESERVATIVE FREE
There are no Therapeutic Equivalents.