FDA.reportPublic FDA data

Application 021259

Type
NDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METADATE CDMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL20MGYesNo
002METADATE CDMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MGYesNo
003METADATE CDMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MGYesNo
004METADATE CDMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL40MGYesNo
005METADATE CDMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL50MGYesNo
006METADATE CDMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL60MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-4579methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4579methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4579methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4579methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4580methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4580methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4580methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4580methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4581methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4581methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4581methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4581methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4582methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4582methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4582methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4582methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4583methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4583methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4583methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4583methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4584methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4584methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4584methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-4584methylphenidate hydrochloride CDmethylphenidate hydrochlorideLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
53014-579Metadate CDmethylphenidate hydrochlorideUnither Manufacturing, LLCNDACurrent
53014-580Metadate CDmethylphenidate hydrochlorideUnither Manufacturing, LLCNDACurrent
53014-581Metadate CDmethylphenidate hydrochlorideUnither Manufacturing, LLCNDACurrent
53014-582Metadate CDmethylphenidate hydrochlorideUnither Manufacturing, LLCNDACurrent
53014-583Metadate CDmethylphenidate hydrochlorideUnither Manufacturing, LLCNDACurrent
53014-584Metadate CDmethylphenidate hydrochlorideUnither Manufacturing, LLCNDACurrent
62175-151methylphenidate hydrochloride CDmethylphenidate hydrochlorideKremers Urban Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
62175-152methylphenidate hydrochloride CDmethylphenidate hydrochlorideKremers Urban Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
62175-153methylphenidate hydrochloride CDmethylphenidate hydrochlorideKremers Urban Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
62175-154methylphenidate hydrochloride CDmethylphenidate hydrochlorideKremers Urban Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
62175-154methylphenidate hydrochloride CDmethylphenidate hydrochlorideKremers Urban Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
62175-155methylphenidate hydrochloride CDmethylphenidate hydrochlorideKremers Urban Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
62175-156methylphenidate hydrochloride CDmethylphenidate hydrochlorideKremers Urban Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
65084-468Metadate CDmethylphenidate hydrochlorideMckesson Rxpak IncNDACurrent
65084-469Metadate CDmethylphenidate hydrochlorideMckesson Rxpak IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83500SUPPL 2025-09-25
83499SUPPL 2025-09-25
83438SUPPL 2025-09-25
75823SUPPL 2023-10-17
75754SUPPL 2023-10-16
70833SUPPL2022-04-27
70832SUPPL2022-04-27
70809SUPPL2022-04-26
67965SUPPL2021-06-29
67964SUPPL2021-06-29
67946SUPPL2021-06-29
46757SUPPL2017-01-10
46756SUPPL2017-01-10
46707SUPPL2017-01-06
36495SUPPL2015-04-21
27248SUPPL2015-04-20
27247SUPPL2013-12-17
14775SUPPL2013-12-17
14774SUPPL2013-06-11
4815SUPPL2013-06-06
27246SUPPL2013-05-07
4814SUPPL2013-05-07
36494SUPPL2013-05-06
36493SUPPL2013-05-06
27245SUPPL2010-10-20
14773SUPPL2010-10-18
27244SUPPL2009-05-14
36492SUPPL2009-04-23
36491SUPPL2008-08-29
4813SUPPL2008-08-28
44109ORIG2007-05-18
27243SUPPL2007-05-09
14772SUPPL2007-05-07
4812SUPPL2006-08-14
36490SUPPL2006-08-11
27242SUPPL2006-03-01
4809ORIG2004-06-09
42058ORIG2003-12-31
27241SUPPL2003-09-29
4811SUPPL2003-06-22
27240SUPPL2003-06-08
14771SUPPL2002-04-09
4810SUPPL2002-04-09
14770ORIG2001-04-03