Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210452
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
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 |
---|---|---|---|---|---|---|---|
09/26/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210452Orig1s000ltr.pdf |
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 |