Details for New Drug Application (NDA): 209253
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NDA 209253 describes AMPHETAMINE, which is a drug marketed by Actavis Labs Fl Inc, Alkem Labs Ltd, Amneal Pharms, Aurolife Pharma Llc, Bionpharma, Dr Reddys Labs Sa, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Lannett, Novast Labs, Prinston Inc, Rhodes Pharms, Sanaluz, Senores Pharms, Specgx Llc, and Sun Pharm Inds Inc, and is included in seventeen NDAs. It is available from one supplier. Additional details are available on the AMPHETAMINE profile page.
The generic ingredient in AMPHETAMINE is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
The generic ingredient in AMPHETAMINE is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 209253
| Tradename: | AMPHETAMINE |
| Applicant: | Actavis Labs Fl Inc |
| Ingredient: | amphetamine |
| Patents: | 0 |
Pharmacology for NDA: 209253
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 209253
Suppliers and Packaging for NDA: 209253
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPHETAMINE | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 209253 | ANDA | Teva Pharmaceuticals, Inc. | 0480-3315 | 0480-3315-65 | 30 BLISTER PACK in 1 CARTON (0480-3315-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| AMPHETAMINE | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 209253 | ANDA | Teva Pharmaceuticals, Inc. | 0480-3316 | 0480-3316-65 | 30 BLISTER PACK in 1 CARTON (0480-3316-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Strength | EQ 3.1MG BASE | ||||
| Approval Date: | Jun 22, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Strength | EQ 6.3MG BASE | ||||
| Approval Date: | Jun 22, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Strength | EQ 9.4MG BASE | ||||
| Approval Date: | Jun 22, 2023 | TE: | AB | RLD: | No | ||||
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