Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062752
Company: CHARTWELL TETRA
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 |
---|---|---|---|---|---|---|---|---|
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 | 212635 | STRIDES PHARMA |
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 |
---|---|---|---|---|---|---|---|---|
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 | 212635 | STRIDES PHARMA |
TETRACYCLINE HYDROCHLORIDE | TETRACYCLINE HYDROCHLORIDE | 500MG | CAPSULE;ORAL | Prescription | No | AB | 061837 | WATSON LABS |