Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080737
Company: AM REGENT
Company: AM REGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/26/1972 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/24/2021 | SUPPL-40 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/080737Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/080737Orig1s040ltr.pdf | |
| 06/27/2002 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/2002 | SUPPL-22 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/14/2001 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 05/14/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-18 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/17/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/29/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/16/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/24/2021 | SUPPL-40 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/080737Orig1s040lbl.pdf |
CYANOCOBALAMIN
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 080737 | AM REGENT |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213874 | EUGIA PHARMA |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214390 | GLAND PHARMA LTD |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204829 | MYLAN LABS LTD |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215107 | SAGENT PHARMS INC |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212915 | SANDOZ |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215417 | SOLA PHARMS |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206503 | SOMERSET THERAPS LLC |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209429 | SOMERSET THERAPS LLC |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209255 | VITRUVIAS THERAP |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 080515 | WEST-WARD PHARMS INT |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214655 | ZYDUS PHARMS |
| DODEX | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 083022 | ACCORD HLTHCARE |
| VIBISONE | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 080557 | FRESENIUS KABI USA |