Abacavir and Lamivudine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Burel Pharma. The primary component is Abacavir Sulfate; Lamivudine.
| Product ID | 35573-402_3f620fa4-3749-4080-ab3c-92b3f8120de8 |
| NDC | 35573-402 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Abacavir and Lamivudine |
| Generic Name | Abacavir And Lamivudine |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-03-28 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206151 |
| Labeler Name | Burel Pharma |
| Substance Name | ABACAVIR SULFATE; LAMIVUDINE |
| Active Ingredient Strength | 600 mg/1; mg/1 |
| Pharm Classes | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2017-03-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206151 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-03-28 |
| Ingredient | Strength |
|---|---|
| ABACAVIR SULFATE | 600 mg/1 |
| SPL SET ID: | 9d86b3a9-2222-49e4-ba7f-c307a8f7f9f7 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-5382 | Abacavir and Lamivudine | Abacavir and Lamivudine |
| 35573-402 | Abacavir and Lamivudine | Abacavir and Lamivudine |
| 35573-430 | Abacavir and Lamivudine | Abacavir and Lamivudine |
| 42291-115 | Abacavir and Lamivudine | Abacavir and Lamivudine |
| 42385-962 | Abacavir and Lamivudine | Abacavir and Lamivudine |
| 65862-335 | Abacavir and Lamivudine | Abacavir and Lamivudine |
| 65862-900 | Abacavir and Lamivudine | Abacavir and Lamivudine |
| 66993-482 | Abacavir and Lamivudine | abacavir sulfate and lamivudine |
| 68180-288 | Abacavir and Lamivudine | Abacavir and Lamivudine |
| 69097-362 | Abacavir and Lamivudine | Abacavir and lamivudine |
| 70518-0715 | Abacavir and Lamivudine | Abacavir and Lamivudine |
| 70710-1049 | Abacavir and lamivudine | Abacavir and lamivudine |
| 70771-1053 | Abacavir and lamivudine | Abacavir and lamivudine |