Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065200
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GRISEOFULVIN | GRISEOFULVIN, MICROSIZE | 125MG/5ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
03/02/2005 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/065200_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/31/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
GRISEOFULVIN
SUSPENSION;ORAL; 125MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GRISEOFULVIN | GRISEOFULVIN, MICROSIZE | 125MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 065394 | ACTAVIS MID ATLANTIC |
GRISEOFULVIN | GRISEOFULVIN, MICROSIZE | 125MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 065200 | CHARTWELL RX |
GRISEOFULVIN | GRISEOFULVIN, MICROSIZE | 125MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 065354 | CIPLA |
GRISEOFULVIN | GRISEOFULVIN, MICROSIZE | 125MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 065438 | COSETTE |