Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060569
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FULVICIN-U/F | GRISEOFULVIN, MICROSIZE | 500MG | TABLET;ORAL | Prescription | AB | No | No |
FULVICIN-U/F | GRISEOFULVIN, MICROSIZE | 250MG | TABLET;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 |
---|---|---|---|---|---|---|---|
09/09/1971 | 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 |
---|---|---|---|---|---|
01/26/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
FULVICIN-U/F
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 |
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 |