Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020458
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GALZIN | ZINC ACETATE | EQ 25MG ZINC | CAPSULE;ORAL | Prescription | None | Yes | No |
GALZIN | ZINC ACETATE | EQ 50MG ZINC | CAPSULE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/28/1997 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD; Orphan |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020458ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/25/2024 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020458s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020458Orig1s009ltr.pdf | |
01/05/2016 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/22/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/01/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/14/2002 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20458s2ltr.pdf |
05/19/1998 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/25/2024 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020458s009lbl.pdf |