Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091601
Company: TRIS PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription AA No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription AA 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
07/23/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091601s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/19/2013 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

METHYLPHENIDATE HYDROCHLORIDE

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLIN METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription Yes AA 021419 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 207485 ABHAI LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 211647 ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 210764 ANDA REPOSITORY
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 207417 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 201466 BRECKENRIDGE
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 210139 EYWA
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 204602 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 213567 QUAGEN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 091601 TRIS PHARMA INC

SOLUTION;ORAL; 10MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLIN METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription Yes AA 021419 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription No AA 207485 ABHAI LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription No AA 211647 ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription No AA 210764 ANDA REPOSITORY
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription No AA 207417 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription No AA 201466 BRECKENRIDGE
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription No AA 210139 EYWA
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription No AA 204602 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription No AA 213567 QUAGEN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription No AA 091601 TRIS PHARMA INC

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