Viewing data from:

METHYLIN ER

ANDA

METHYLPHENIDATE HYDROCHLORIDE | A075629 | SPECGX LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CONCERTA(TE code: AB)

API Supply Chain10 active DMFs5 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

VERANOVA LPMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 101371993

SPECGX LLCMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 127691997

CAMBREX CHARLES CITY INCMETHYLPHENIDATE HYDROCHLORIDE (RITALIN HCL)

DMF 166102003

CURIA MISSOURI INCMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 190632005

NORAMCO LLCMETHYLPHENIDATE HYDROCHLORIDE

DMF 222442008

SPECGX LLCMETHYLPHENIDATE HYDROCHLORIDE USP (NP)

DMF 257762013

JANSSEN RESEARCH AND DEVELOPMENT LLCMETHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS I)

DMF 305102016

JANSSEN RESEARCH AND DEVELOPMENT LLCMETHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS II)

DMF 305462021

ALKEM LABORATORIES LTDMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 306822016

SIEGFRIED USA LLCMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 342742019

SIEGFRIED USA LLCInactiveMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 129891998

BOEHRINGER INGELHEIM CHEMICALS INCInactiveMETHYLPHENIDATE HYDROCHLORIDE

DMF 154852001

IPCA LABORATORIES LTDInactiveMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 206212007

MACFARLAN SMITH LTDInactiveMETHYLPHENIDATE HYDROCHLORIDE

DMF 305792016

CODY LABORATORIES INCInactiveMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 335092019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 9, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 9, 2000

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 9, 2000