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Abbreviated New Drug Application (ANDA): 212184
Company: GLENMARK PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOPHYLLINE THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
THEOPHYLLINE THEOPHYLLINE 450MG TABLET, 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
06/03/2021 ORIG-1 Approval STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212184Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/212184Orig1s000TOC.cfm

THEOPHYLLINE

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THEOPHYLLINE THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090430 ALEMBIC PHARMS
THEOPHYLLINE THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212184 GLENMARK PHARMS LTD
THEOPHYLLINE THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 089763 HERITAGE PHARMA AVET
THEOPHYLLINE THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 216961 TEVA PHARMS INC

TABLET, EXTENDED RELEASE;ORAL; 450MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THEOPHYLLINE THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090430 ALEMBIC PHARMS
THEOPHYLLINE THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212184 GLENMARK PHARMS LTD
THEOPHYLLINE THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 081236 HERITAGE PHARMA AVET
THEOPHYLLINE THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 216961 TEVA PHARMS INC
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