DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 211139
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
NDA 211139 describes AMPHETAMINE SULFATE, which is a drug marketed by Amneal Pharms, Aurolife Pharma Llc, Granules Pharms, and Lannett, and is included in four NDAs. It is available from three suppliers. Additional details are available on the AMPHETAMINE SULFATE profile page.
The generic ingredient in AMPHETAMINE SULFATE is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
The generic ingredient in AMPHETAMINE SULFATE is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 211139
| Tradename: | AMPHETAMINE SULFATE |
| Applicant: | Amneal Pharms |
| Ingredient: | amphetamine sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211139
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 211139
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 211139 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1563 | 69238-1563-1 | 100 TABLET in 1 BOTTLE (69238-1563-1) |
| AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 211139 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1564 | 69238-1564-1 | 100 TABLET in 1 BOTTLE (69238-1564-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Sep 26, 2018 | TE: | AA | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 26, 2019 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 26, 2018 | TE: | AA | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 30, 2019 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Complete Access Available with Subscription
