Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062752
Company: CHARTWELL TETRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription AB No No
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;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
08/12/1988 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2016 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

01/27/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACHROMYCIN V TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription Yes AB 050278 HERITAGE PHARMS INC
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 210674 AMNEAL PHARMS NY
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 210662 BRECKENRIDGE
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 062752 CHARTWELL TETRA
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 061837 WATSON LABS

CAPSULE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACHROMYCIN V TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Prescription Yes AB 050278 HERITAGE PHARMS INC
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Prescription No AB 210674 AMNEAL PHARMS NY
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Prescription No AB 210662 BRECKENRIDGE
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Prescription No AB 062752 CHARTWELL TETRA
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Prescription No AB 061837 WATSON LABS

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