Details for New Drug Application (NDA): 216554
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NDA 216554 describes AMPICILLIN TRIHYDRATE, which is a drug marketed by Aurobindo Pharma, Belcher Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Lederle, Mylan, Purepac Pharm, Sandoz, Strides Pharma, Vitarine, Endo Operations, and Teva, and is included in sixteen NDAs. It is available from three suppliers. Additional details are available on the AMPICILLIN TRIHYDRATE profile page.
The generic ingredient in AMPICILLIN TRIHYDRATE is ampicillin/ampicillin trihydrate. Three suppliers are listed for this compound. Additional details are available on the ampicillin/ampicillin trihydrate profile page.
The generic ingredient in AMPICILLIN TRIHYDRATE is ampicillin/ampicillin trihydrate. Three suppliers are listed for this compound. Additional details are available on the ampicillin/ampicillin trihydrate profile page.
Summary for 216554
| Tradename: | AMPICILLIN TRIHYDRATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | ampicillin/ampicillin trihydrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216554
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN TRIHYDRATE | ampicillin/ampicillin trihydrate | CAPSULE;ORAL | 216554 | ANDA | Aurobindo Pharma Limited | 59651-550 | 59651-550-01 | 100 CAPSULE in 1 BOTTLE (59651-550-01) |
| AMPICILLIN TRIHYDRATE | ampicillin/ampicillin trihydrate | CAPSULE;ORAL | 216554 | ANDA | Aurobindo Pharma Limited | 59651-550 | 59651-550-05 | 500 CAPSULE in 1 BOTTLE (59651-550-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Oct 31, 2023 | TE: | RLD: | No | |||||
| Regulatory Exclusivity Expiration: | Jun 3, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Oct 31, 2023 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jun 3, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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