Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018642
Company: COSETTE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETA-VAL BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;TOPICAL 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
03/24/1983 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
11/22/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/30/2001 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

01/12/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/13/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/14/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/09/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/09/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/09/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/30/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/30/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/21/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/15/1988 SUPPL-4 Labeling

Label is not available on this site.

09/10/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

BETA-VAL

CREAM;TOPICAL; EQ 0.1% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETA-VAL BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;TOPICAL Prescription No AB 018642 COSETTE
BETAMETHASONE VALERATE BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;TOPICAL Prescription Yes AB 018861 FOUGERA PHARMS INC
DERMABET BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;TOPICAL Prescription No AB 072041 TARO
VALNAC BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;TOPICAL Prescription No AB 070050 ACTAVIS MID ATLANTIC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English