Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078873
Company: TEVA PHARMS

Products on ANDA 078873

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB2	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	50MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB2	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078873

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/19/2012	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/078873Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/2022	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/06/2022	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/06/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/06/2022	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/06/2022	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/22/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/22/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078873

METHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB2	021259	AYTU BIOPHARMA
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	205105	IMPAX LABS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	203583	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	078873	TEVA PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	50MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB2	021259	AYTU BIOPHARMA
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	50MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	205105	IMPAX LABS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	50MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	203583	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	50MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	078873	TEVA PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB2	021259	AYTU BIOPHARMA
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	205105	IMPAX LABS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	203583	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	078873	TEVA PHARMS