Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018865
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETAMETHASONE VALERATE BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/31/1983 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
01/20/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/12/1996 SUPPL-11 Labeling

Label is not available on this site.

03/07/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/29/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/14/1988 SUPPL-8 Labeling

Label is not available on this site.

10/24/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/23/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/23/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

BETAMETHASONE VALERATE

OINTMENT;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 OINTMENT;TOPICAL Prescription No AB 070069 COSETTE
BETAMETHASONE VALERATE BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription No AB 070051 ACTAVIS MID ATLANTIC
BETAMETHASONE VALERATE BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription Yes AB 018865 FOUGERA PHARMS INC

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