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Abbreviated New Drug Application (ANDA): 210876
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125MG;3.125MG;3.125MG;3.125MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 9.375MG;9.375MG;9.375MG;9.375MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 12.5MG;12.5MG;12.5MG;12.5MG CAPSULE, EXTENDED RELEASE;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
01/31/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210876Orig1s000ltr.pdf

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

CAPSULE, EXTENDED RELEASE;ORAL; 3.125MG;3.125MG;3.125MG;3.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125MG;3.125MG;3.125MG;3.125MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210876 TEVA PHARMS USA

CAPSULE, EXTENDED RELEASE;ORAL; 6.25MG;6.25MG;6.25MG;6.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADDERALL XR 25 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021303 TAKEDA PHARMS USA
DETROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 214959 ASCENT PHARMS INC
DETROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 214403 LANNETT CO INC
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 077302 ACTAVIS ELIZABETH
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205401 ANI PHARMS
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212037 ELITE LABS INC
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076852 IMPAX LABS
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206159 PAR PHARM INC
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210651 RHODES PHARMS
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 211547 SPECGX LLC
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 211715 SUN PHARM INDUSTRIES
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210876 TEVA PHARMS USA

CAPSULE, EXTENDED RELEASE;ORAL; 9.375MG;9.375MG;9.375MG;9.375MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 9.375MG;9.375MG;9.375MG;9.375MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210876 TEVA PHARMS USA

CAPSULE, EXTENDED RELEASE;ORAL; 12.5MG;12.5MG;12.5MG;12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 12.5MG;12.5MG;12.5MG;12.5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210876 TEVA PHARMS USA

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