Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | 125MG | TABLET;ORAL | Prescription | AB | Yes | No |
| GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | 250MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/16/1975 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/19/2016 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050475s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050475Orig1s057ltr.pdf | |
| 05/08/2013 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/2010 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050475s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050475s054ltr.pdf | |
| 01/24/2007 | SUPPL-53 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050475s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050475s053ltr.pdf | |
| 08/01/2002 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/2002 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/02/2001 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/2000 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1998 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/2003 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50475slr046_gris-peg_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50475slr046ltr.pdf | |
| 04/07/1997 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/1982 | SUPPL-44 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/21/1982 | SUPPL-43 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/28/1982 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 02/05/1982 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/06/1981 | SUPPL-37 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/05/1981 | SUPPL-34 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/13/1980 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 11/21/1980 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 01/04/1980 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/1980 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/21/1980 | SUPPL-27 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/10/1979 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/21/1980 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 01/17/1978 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1977 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/20/1977 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1976 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1976 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/18/1976 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1976 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/04/1976 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/16/1976 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/01/1976 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/16/1976 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/1975 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1975 | SUPPL-9 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/20/1988 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/16/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/24/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1983 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/26/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/19/2016 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050475s057lbl.pdf | |
| 10/19/2010 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050475s054lbl.pdf | |
| 01/24/2007 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050475s053lbl.pdf | |
| 03/26/2003 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50475slr046_gris-peg_lbl.pdf |
GRIS-PEG
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 |