Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202545
Company: SIGMAPHARM LABS LLC
Company: SIGMAPHARM LABS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GRISEOFULVIN,ULTRAMICROSIZE | GRISEOFULVIN, ULTRAMICROSIZE | 125MG | TABLET;ORAL | Prescription | AB | No | No |
GRISEOFULVIN,ULTRAMICROSIZE | GRISEOFULVIN, ULTRAMICROSIZE | 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 |
---|---|---|---|---|---|---|---|
10/22/2012 | ORIG-1 | Approval |
Label is not available on this site. |
GRISEOFULVIN,ULTRAMICROSIZE
TABLET;ORAL; 125MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FULVICIN P/G | GRISEOFULVIN, ULTRAMICROSIZE | 125MG | TABLET;ORAL | Prescription | No | AB | 061996 | CHARTWELL RX |
GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | 125MG | TABLET;ORAL | Prescription | Yes | AB | 050475 | BAUSCH |
GRISEOFULVIN, ULTRAMICROSIZE | GRISEOFULVIN, ULTRAMICROSIZE | 125MG | TABLET;ORAL | Prescription | No | AB | 204371 | MOUNTAIN |
GRISEOFULVIN, ULTRAMICROSIZE | GRISEOFULVIN, ULTRAMICROSIZE | 125MG | TABLET;ORAL | Prescription | No | AB | 202805 | SANDOZ |
GRISEOFULVIN,ULTRAMICROSIZE | GRISEOFULVIN, ULTRAMICROSIZE | 125MG | TABLET;ORAL | Prescription | No | AB | 202545 | 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 P/G | GRISEOFULVIN, ULTRAMICROSIZE | 250MG | TABLET;ORAL | Prescription | No | AB | 061996 | CHARTWELL RX |
GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | 250MG | TABLET;ORAL | Prescription | Yes | AB | 050475 | BAUSCH |
GRISEOFULVIN, ULTRAMICROSIZE | GRISEOFULVIN, ULTRAMICROSIZE | 250MG | TABLET;ORAL | Prescription | No | AB | 204371 | MOUNTAIN |
GRISEOFULVIN, ULTRAMICROSIZE | GRISEOFULVIN, ULTRAMICROSIZE | 250MG | TABLET;ORAL | Prescription | No | AB | 202805 | SANDOZ |
GRISEOFULVIN,ULTRAMICROSIZE | GRISEOFULVIN, ULTRAMICROSIZE | 250MG | TABLET;ORAL | Prescription | No | AB | 202545 | SIGMAPHARM LABS LLC |