Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050278
Company: AVET
Company: AVET
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACHROMYCIN V | TETRACYCLINE HYDROCHLORIDE | 500MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| ACHROMYCIN V | TETRACYCLINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 10/08/1957 | ORIG-1 | Approval | UNKNOWN |
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-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050278s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/050278Orig1s049ltr.pdf | |
| 05/19/2016 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/2016 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/2015 | SUPPL-37 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050278s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050278Orig1s037ltr.pdf |
| 04/21/2015 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1999 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/26/1961 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 03/16/1961 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 01/16/1961 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/20/1960 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/02/1960 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1959 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/13/1959 | SUPPL-25 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/01/1958 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/15/1958 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/15/1958 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/28/1958 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/25/1958 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/15/1992 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/31/2025 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050278s049lbl.pdf | |
| 04/27/2015 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050278s037lbl.pdf |
| 04/27/2015 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050278s037lbl.pdf |
ACHROMYCIN V
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 |
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 |