Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008453
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANECTINE | SUCCINYLCHOLINE CHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ANECTINE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| ANECTINE | SUCCINYLCHOLINE CHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ANECTINE | SUCCINYLCHOLINE CHLORIDE | 1GM/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 |
|---|---|---|---|---|---|---|---|
| 08/20/1952 | 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 |
|---|---|---|---|---|---|
| 11/21/2023 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/01/2022 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008453s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/008453Orig1s040ltr.pdf | |
| 12/20/2020 | SUPPL-37 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/008453Orig1s037ltr.pdf |
| 07/26/2018 | SUPPL-36 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008453s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008453Orig1s036Ltr.pdf | |
| 06/23/2017 | SUPPL-33 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/25/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/2010 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008453s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/008453s027ltr.pdf | |
| 10/02/2000 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/10/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/26/2000 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/29/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/10/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/01/1985 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/11/1982 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf |
| 05/15/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/12/1981 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/22/1981 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/21/1980 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/22/1985 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/30/1978 | SUPPL-6 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf |
| 12/05/1975 | SUPPL-4 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf |
| 06/22/1973 | SUPPL-1 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/01/2022 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008453s040lbl.pdf | |
| 07/26/2018 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008453s036lbl.pdf | |
| 07/26/2018 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008453s036lbl.pdf | |
| 11/22/2010 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008453s027lbl.pdf |
ANECTINE
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 | 214308 | ADAPTIS |
| 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 | 214246 | GLAND PHARMA LTD |
| 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 | 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 |