اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ACHROMYCIN V از شرکت LEDERLE
New Drug Application (NDA): 050263
Company: LEDERLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACHROMYCIN V | TETRACYCLINE HYDROCHLORIDE | 125MG/5ML | SUSPENSION;ORAL | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 01/27/1955 | 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 |
|---|---|---|---|---|---|
| 03/22/1983 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1982 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1979 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 10/11/1978 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1976 | SUPPL-63 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/19/1973 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 09/05/1972 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 09/29/1971 | SUPPL-60 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/02/1971 | SUPPL-59 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/26/1971 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 07/14/1971 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 10/26/1970 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 01/05/1970 | SUPPL-55 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/23/1969 | SUPPL-54 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/12/1968 | SUPPL-53 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/24/1967 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/17/1966 | SUPPL-50 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/17/1966 | SUPPL-49 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/29/1965 | SUPPL-47 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/18/1964 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 08/10/1964 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 06/23/1964 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 06/19/1964 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 10/18/1963 | SUPPL-40 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/18/1963 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 06/18/1963 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 06/04/1963 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 05/27/1963 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 04/16/1962 | SUPPL-34 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/13/1962 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 02/13/1962 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 10/30/1961 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 07/24/1961 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 05/31/1961 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/17/1961 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/15/1961 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 02/17/1961 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/31/1961 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/22/1960 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/01/1958 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/15/1958 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 06/13/1958 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/17/1958 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/18/1958 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/19/1959 | SUPPL-18 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/18/1957 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/18/1957 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/25/1957 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/25/1957 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/1957 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/1957 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/25/1957 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/15/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/15/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/13/1955 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/06/1955 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1955 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
نظرات کاربران