Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 12/24/1974 | 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 |
|---|---|---|---|---|---|
| 03/31/2025 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/14/2025 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/14/2025 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/20/2002 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/10/1999 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1999 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/01/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/14/1989 | SUPPL-7 | 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 | AVET |
| 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 | NOVITIUM 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 |
|---|---|---|---|---|---|---|---|---|
| ACHROMYCIN V | TETRACYCLINE HYDROCHLORIDE | 500MG | CAPSULE;ORAL | Prescription | Yes | AB | 050278 | AVET |
| 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 | NOVITIUM PHARMA |
| TETRACYCLINE HYDROCHLORIDE | TETRACYCLINE HYDROCHLORIDE | 500MG | CAPSULE;ORAL | Prescription | No | AB | 061837 | WATSON LABS |