Details for New Drug Application (NDA): 214548
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The generic ingredient in AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
Summary for 214548
Tradename: | AMITRIPTYLINE HYDROCHLORIDE |
Applicant: | Unichem |
Ingredient: | amitriptyline hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 214548
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 214548 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-419 | 29300-419-01 | 100 TABLET, FILM COATED in 1 BOTTLE (29300-419-01) |
AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 214548 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-419 | 29300-419-05 | 500 TABLET, FILM COATED in 1 BOTTLE (29300-419-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | May 19, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | May 19, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | May 19, 2021 | TE: | AB | RLD: | No |
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