Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 206490
Company: PACK PHARMS LLC
Company: PACK PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 11/05/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NORETHINDRONE ACETATE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 200275 | AMNEAL PHARMS |
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 204236 | AUROBINDO PHARMA LTD |
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075951 | BARR |
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 091090 | GLENMARK GENERICS |
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 205278 | MYLAN LABS LTD |
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 206490 | PACK PHARMS LLC |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English