Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203934
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | AB2 | No | No |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | AB2 | No | No |
| GABAPENTIN | GABAPENTIN | 450MG | TABLET;ORAL | Prescription | AB | No | No |
| GABAPENTIN | GABAPENTIN | 750MG | TABLET;ORAL | Prescription | AB | No | No |
| GABAPENTIN | GABAPENTIN | 900MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/24/2024 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203934Orig1s000TA_ltr.pdf |
GABAPENTIN
TABLET;ORAL; 300MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | No | AB2 | 218075 | ANNORA PHARMA |
| GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | No | AB2 | 216252 | HUMANWELL |
| GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | No | AB2 | 218491 | SCIEGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | No | AB2 | 203934 | ZYDUS PHARMS |
| GRALISE | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | Yes | AB2 | 022544 | ALMATICA |
TABLET;ORAL; 600MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB2 | 203643 | ABON PHARMS LLC |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB2 | 218075 | ANNORA PHARMA |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB2 | 216252 | HUMANWELL |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB2 | 218491 | SCIEGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB2 | 203934 | ZYDUS PHARMS |
| GRALISE | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | Yes | AB2 | 022544 | ALMATICA |
TABLET;ORAL; 450MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 450MG | TABLET;ORAL | Prescription | No | AB | 203934 | ZYDUS PHARMS |
| GRALISE | GABAPENTIN | 450MG | TABLET;ORAL | Prescription | Yes | AB | 022544 | ALMATICA |
TABLET;ORAL; 750MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 750MG | TABLET;ORAL | Prescription | No | AB | 203934 | ZYDUS PHARMS |
| GRALISE | GABAPENTIN | 750MG | TABLET;ORAL | Prescription | Yes | AB | 022544 | ALMATICA |
TABLET;ORAL; 900MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 900MG | TABLET;ORAL | Prescription | No | AB | 203934 | ZYDUS PHARMS |
| GRALISE | GABAPENTIN | 900MG | TABLET;ORAL | Prescription | Yes | AB | 022544 | ALMATICA |