Acetyl - Generic Drug Details
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Generic filers with tentative approvals for ACETYL
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for Acetyl
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | ACYLANID | acetyldigitoxin | TABLET;ORAL | 009436-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Cumberland Pharms | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539-001 | Jan 23, 2004 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Cumberland Pharms | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539-001 | Jan 23, 2004 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Onesource Specialty | ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 217182-001 | Apr 19, 2023 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hospira | ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 073664-001 | Aug 30, 1994 | AN | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Novartis | MIOCHOL | acetylcholine chloride | FOR SOLUTION;OPHTHALMIC | 016211-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |

