Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075410
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;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
11/01/2002 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75410TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075410.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2018 SUPPL-57 Labeling-Package Insert

Label is not available on this site.

05/31/2018 SUPPL-55 Labeling-Package Insert

Label is not available on this site.

02/25/2016 SUPPL-51 Labeling-Package Insert

Label is not available on this site.

02/27/2015 SUPPL-49 Labeling-Package Insert

Label is not available on this site.

02/27/2015 SUPPL-48 Labeling-Package Insert

Label is not available on this site.

02/27/2015 SUPPL-45 Labeling-Package Insert

Label is not available on this site.

01/30/2015 SUPPL-43 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

02/27/2015 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

11/02/2012 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

02/16/2012 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

02/16/2012 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

02/16/2012 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

02/16/2012 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

11/17/2010 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

11/17/2010 SUPPL-31 Labeling-Container/Carton Labels

Label is not available on this site.

03/21/2007 SUPPL-27 Labeling

Label is not available on this site.

03/21/2007 SUPPL-25 Labeling

Label is not available on this site.

09/26/2006 SUPPL-24 Labeling

Label is not available on this site.

07/14/2004 SUPPL-20 Labeling

Label is not available on this site.

01/23/2009 SUPPL-16 Labeling

Label is not available on this site.

03/24/2005 SUPPL-15 Manufacturing (CMC)-New Strength

Label is not available on this site.

02/13/2004 SUPPL-13 Labeling

Label is not available on this site.

04/29/2004 SUPPL-9 Labeling

Label is not available on this site.

08/06/2003 SUPPL-8 Labeling

Label is not available on this site.

OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075347 ACTAVIS LABS FL INC
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076048 APOTEX
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203270 AUROBINDO PHARMA LTD
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203481 BRECKENRIDGE
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075576 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078490 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091672 GLENMARK GENERICS
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 204012 HETERO LABS LTD III
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075785 IMPAX LABS
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075410 LANNETT CO INC
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205070 MYLAN
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075757 SANDOZ
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091352 ZYDUS PHARMS USA INC

CAPSULE, DELAYED REL PELLETS;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075347 ACTAVIS LABS FL INC
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076048 APOTEX
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203270 AUROBINDO PHARMA LTD
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203481 BRECKENRIDGE
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075576 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078490 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091672 GLENMARK GENERICS
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 204012 HETERO LABS LTD III
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075785 IMPAX LABS
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075410 LANNETT CO INC
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075876 MYLAN
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205070 MYLAN
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075757 SANDOZ
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 204661 TEVA PHARMS USA
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091352 ZYDUS PHARMS USA INC

CAPSULE, DELAYED REL PELLETS;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075347 ACTAVIS LABS FL INC
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076048 APOTEX
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203270 AUROBINDO PHARMA LTD
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203481 BRECKENRIDGE
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075576 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078490 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091672 GLENMARK GENERICS
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075785 IMPAX LABS
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075410 LANNETT CO INC
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202384 LUPIN LTD
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205070 MYLAN
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076515 SANDOZ
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 204661 TEVA PHARMS USA
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091352 ZYDUS PHARMS USA INC

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