Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205360
Company: AVET
Company: AVET
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 0.5MCG | CAPSULE;ORAL | Prescription | AB | No | No |
DOXERCALCIFEROL | DOXERCALCIFEROL | 1MCG | CAPSULE;ORAL | Prescription | AB | No | No |
DOXERCALCIFEROL | DOXERCALCIFEROL | 2.5MCG | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
09/15/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DOXERCALCIFEROL
CAPSULE;ORAL; 0.5MCG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 0.5MCG | CAPSULE;ORAL | Prescription | No | AB | 205360 | AVET |
DOXERCALCIFEROL | DOXERCALCIFEROL | 0.5MCG | CAPSULE;ORAL | Prescription | No | AB | 201518 | RISING PHARMA |
HECTOROL | DOXERCALCIFEROL | 0.5MCG | CAPSULE;ORAL | Prescription | Yes | AB | 020862 | SANOFI |
CAPSULE;ORAL; 1MCG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 1MCG | CAPSULE;ORAL | Prescription | No | AB | 205360 | AVET |
DOXERCALCIFEROL | DOXERCALCIFEROL | 1MCG | CAPSULE;ORAL | Prescription | No | AB | 201518 | RISING PHARMA |
HECTOROL | DOXERCALCIFEROL | 1MCG | CAPSULE;ORAL | Prescription | Yes | AB | 020862 | SANOFI |
CAPSULE;ORAL; 2.5MCG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 2.5MCG | CAPSULE;ORAL | Prescription | No | AB | 205360 | AVET |
DOXERCALCIFEROL | DOXERCALCIFEROL | 2.5MCG | CAPSULE;ORAL | Prescription | No | AB | 201518 | RISING PHARMA |
HECTOROL | DOXERCALCIFEROL | 2.5MCG | CAPSULE;ORAL | Prescription | Yes | AB | 020862 | SANOFI |