Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091592
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GRISEOFULVIN | GRISEOFULVIN, MICROSIZE | 250MG | TABLET;ORAL | Prescription | AB | No | No |
GRISEOFULVIN | GRISEOFULVIN, MICROSIZE | 500MG | TABLET;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
08/07/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
GRISEOFULVIN
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FULVICIN-U/F | GRISEOFULVIN, MICROSIZE | 250MG | TABLET;ORAL | Prescription | No | AB | 060569 | CHARTWELL RX |
GRISEOFULVIN | GRISEOFULVIN, MICROSIZE | 250MG | TABLET;ORAL | Prescription | No | AB | 091592 | SANDOZ |
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FULVICIN-U/F | GRISEOFULVIN, MICROSIZE | 500MG | TABLET;ORAL | Prescription | No | AB | 060569 | CHARTWELL RX |
GRISEOFULVIN | GRISEOFULVIN, MICROSIZE | 500MG | TABLET;ORAL | Prescription | No | AB | 091592 | SANDOZ |
GRISEOFULVIN | GRISEOFULVIN, MICROSIZE | 500MG | TABLET;ORAL | Prescription | No | AB | 202482 | SIGMAPHARM LABS LLC |