Details for New Drug Application (NDA): 091526
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NDA 091526 describes DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Abraxis Pharm, Dr Reddys, Fresenius Kabi Usa, and Intl Medication, and is included in four NDAs. It is available from one supplier. Additional details are available on the DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE profile page.
The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
Summary for 091526
| Tradename: | DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | diphenhydramine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 091526
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 091526
Suppliers and Packaging for NDA: 091526
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 091526 | ANDA | Fresenius Kabi USA, LLC | 76045-102 | 76045-102-10 | 24 BLISTER PACK in 1 CARTON (76045-102-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Mar 26, 2013 | TE: | AP | RLD: | No | ||||
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