Details for New Drug Application (NDA): 215408
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The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 215408
Tradename: | DOXEPIN HYDROCHLORIDE |
Applicant: | Teva Pharms |
Ingredient: | doxepin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 215408
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CREAM;TOPICAL | 215408 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-9609 | 0093-9609-95 | 1 TUBE in 1 CARTON (0093-9609-95) / 45 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 5% | ||||
Approval Date: | Feb 17, 2023 | TE: | AB | RLD: | No |
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