Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091333
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
05/05/2014 | 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 |
---|---|---|---|---|---|
11/14/2016 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DOXERCALCIFEROL
INJECTABLE;INJECTION; 4MCG/2ML (2MCG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 215810 | ALEMBIC |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 208975 | AMNEAL |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213717 | EUGIA PHARMA |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210452 | GLAND PHARMA LTD |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091101 | HIKMA |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 208614 | HOSPIRA |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210801 | LUPIN LTD |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 211670 | MEITHEAL |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091333 | SANDOZ |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200926 | SANDOZ |
HECTOROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 021027 | SANOFI |