Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 084840
Company: LANNETT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAZOLAMIDE ACETAZOLAMIDE 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
03/31/1978 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
10/24/2016 SUPPL-26 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/29/2008 SUPPL-23 Labeling

Label is not available on this site.

12/12/2001 SUPPL-19 Labeling

Label is not available on this site.

08/10/2000 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

07/26/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/26/1996 SUPPL-16 Labeling

Label is not available on this site.

07/26/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/26/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/26/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/05/1990 SUPPL-11 Labeling

Label is not available on this site.

05/04/1988 SUPPL-8 Labeling

Label is not available on this site.

06/27/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/16/1981 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

ACETAZOLAMIDE

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 205530 HERITAGE PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 084840 LANNETT
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 209734 STRIDES PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 040195 TARO

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