Details for New Drug Application (NDA): 205532
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NDA 205532 describes LITHIUM CARBONATE, which is a drug marketed by Able, Alembic Ltd, Apotex Inc, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Hikma, Norvium Bioscience, Usl Pharma, Watson Labs, Alembic, Glenmark Pharms Inc, Heritage Pharma, Hikma Intl Pharms, Mylan Pharms Inc, Unique, Pfizer, and Sun Pharm Inds Inc, and is included in twenty-nine NDAs. It is available from twenty-three suppliers. Additional details are available on the LITHIUM CARBONATE profile page.
The generic ingredient in LITHIUM CARBONATE is lithium carbonate. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.
The generic ingredient in LITHIUM CARBONATE is lithium carbonate. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.
Summary for 205532
| Tradename: | LITHIUM CARBONATE |
| Applicant: | Heritage Pharma |
| Ingredient: | lithium carbonate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205532
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LITHIUM CARBONATE | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 205532 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-763 | 23155-763-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (23155-763-01) |
| LITHIUM CARBONATE | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 205532 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-763 | 23155-763-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (23155-763-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Sep 29, 2016 | TE: | AB | RLD: | No | ||||
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